List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
To improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) for drugs with limited competition, FDA is publishing a list, consistent with the methodology described below, of approved new drug application (NDA) drug products that are off-patent and off-exclusivity, and for which the FDA has not approved an ANDA referencing that NDA drug product.
Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.
Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.
The Appendix identifies NDA drug products that were removed from Part I or Part II of the list because one or more ANDAs referencing such NDA drug products have been approved since the previous list publication.
Sponsors wishing to pursue approval of ANDAs referencing drug products identified in Part II of this list generally should submit an initial inquiry to the Office of Generic Drugs at genericdrugs@fda.hhs.gov. Sponsors may be referred to the Office of New Drugs under certain circumstances, for example if the product is a biological product, or if the product is not eligible for submission or approval as an ANDA but may be considered for submission under another abbreviated approval pathway. Sponsors should identify the product’s established name and NDA number in any inquiry.
• For some products in Part II of the list, submission and/or approval of an ANDA via the 505(j) pathway may not be appropriate; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated approval pathway for such products.
• Some products in Part II of the list are biological products that are subject to the transition provisions described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009.
• For other products in Part II of the list, there are regulatory or scientific complexities that may be addressed with additional information exchange between FDA and a prospective ANDA sponsor (e.g., there is no applicable product-specific guidance, or the product is a complex mixture or imaging agent).
We have excluded any NDA drug products that have been approved within the past year, as it generally is too soon for an ANDA referencing such a product to have been approved.
FDA will update the list every six months. The current methodology for creating and reviewing the list is set forth at the bottom of the list. We welcome suggestions concerning the methodology, as well as suggestions for any NDA drug products that should be added to (or, in limited cases, removed from) the list. Please direct correspondence to genericdrugs@fda.hhs.gov, providing your name, e-mail address, phone number, NDA number, established name, and dosage form of any NDA drug product that should be added to or, in limited cases, removed from the list.
Methodology1
Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.
Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.
The Appendix identifies NDA drug products that were removed from Part I or Part II of the list because one or more ANDAs referencing such NDA drug products have been approved since the previous list publication.
Sponsors wishing to pursue approval of ANDAs referencing drug products identified in Part II of this list generally should submit an initial inquiry to the Office of Generic Drugs at genericdrugs@fda.hhs.gov. Sponsors may be referred to the Office of New Drugs under certain circumstances, for example if the product is a biological product, or if the product is not eligible for submission or approval as an ANDA but may be considered for submission under another abbreviated approval pathway. Sponsors should identify the product’s established name and NDA number in any inquiry.
• For some products in Part II of the list, submission and/or approval of an ANDA via the 505(j) pathway may not be appropriate; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated approval pathway for such products.
• Some products in Part II of the list are biological products that are subject to the transition provisions described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009.
• For other products in Part II of the list, there are regulatory or scientific complexities that may be addressed with additional information exchange between FDA and a prospective ANDA sponsor (e.g., there is no applicable product-specific guidance, or the product is a complex mixture or imaging agent).
We have excluded any NDA drug products that have been approved within the past year, as it generally is too soon for an ANDA referencing such a product to have been approved.
FDA will update the list every six months. The current methodology for creating and reviewing the list is set forth at the bottom of the list. We welcome suggestions concerning the methodology, as well as suggestions for any NDA drug products that should be added to (or, in limited cases, removed from) the list. Please direct correspondence to genericdrugs@fda.hhs.gov, providing your name, e-mail address, phone number, NDA number, established name, and dosage form of any NDA drug product that should be added to or, in limited cases, removed from the list.
Part-I
|
Ingredient
|
Approved NDA
|
Dosage Form
|
|
ACETAMINOPHEN
|
N204767
|
SOLUTION
|
|
ACETYLCHOLINE CHLORIDE
|
N020213
|
FOR SOLUTION
|
|
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
|
N019806
|
CAPSULE
|
|
ALBUTEROL SULFATE
|
N020503
|
AEROSOL, METERED
|
|
ALENDRONATE SODIUM; CHOLECALCIFEROL
|
N021762
|
TABLET
|
|
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL;
CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE
HYDROCHLORIDE; RIBOFLAVIN 5'- PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE;
VITAMIN A
PALMITATE; VITAMIN K
|
N021163
|
SOLUTION
|
|
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL;
CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE
HYDROCHLORIDE; RIBOFLAVIN 5'- PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE;
VITAMIN A
PALMITATE; VITAMIN K
|
N021559
|
SOLUTION
|
|
ALPROSTADIL
|
N020700
|
SUPPOSITORY
|
|
AMINO ACIDS
|
N016822
|
INJECTABLE
|
|
AMINO ACIDS
|
N017673
|
INJECTABLE
|
|
AMINO ACIDS
|
N017766
|
INJECTABLE
|
|
AMINO ACIDS
|
N018931
|
INJECTABLE
|
|
AMINO ACIDS
|
N019018
|
INJECTABLE
|
|
AMINO ACIDS
|
N019398
|
INJECTABLE
|
|
AMINO ACIDS
|
N019492
|
INJECTABLE
|
|
AMINO ACIDS
|
N020015
|
INJECTABLE
|
|
AMINO ACIDS
|
N020041
|
INJECTABLE
|
|
AMINO ACIDS
|
N020849
|
INJECTABLE
|
|
AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE;
PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
|
N018582
|
INJECTABLE
|
|
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE;
MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE;
SODIUM CHLORIDE
|
N020678
|
INJECTABLE
|
|
AMINO ACIDS; DEXTROSE
|
N020734
|
INJECTABLE
|
|
AMINO
ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM
CHLORIDE;
SODIUM
ACETATE
|
N016822
|
INJECTABLE
|
|
AMINO
ACIDS; MAGNESIUM ACETATE; PHOSPHORIC
ACID;
POTASSIUM ACETATE; SODIUM CHLORIDE
|
N017789
|
INJECTABLE
|
|
AMINO
ACIDS; MAGNESIUM ACETATE; PHOSPHORIC
ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
|
N016822
|
INJECTABLE
|
|
AMINO
ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM
PHOSPHATE,
DIBASIC
|
N017673
|
INJECTABLE
|
|
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
|
N050824
|
CAPSULE,
TABLET, CAPSULE,
DELAYED
RELEASE
|
|
AMOXICILLIN; CLAVULANATE POTASSIUM
|
N050575
|
FOR SUSPENSION
|
|
AMPHOTERICIN B
|
N050740
|
INJECTABLE, LIPOSOMAL
|
|
APOMORPHINE HYDROCHLORIDE
|
N021264
|
INJECTABLE
|
|
APRACLONIDINE HYDROCHLORIDE
|
N019779
|
SOLUTION/DROPS
|
|
ARGATROBAN
|
N203049
|
INJECTABLE
|
|
ARGATROBAN
|
N206769
|
INJECTABLE
|
|
ARGININE HYDROCHLORIDE
|
N016931
|
INJECTABLE
|
|
ARTEMETHER; LUMEFANTRINE
|
N022268
|
TABLET
|
|
ARTICAINE
HYDROCHLORIDE; EPINEPHRINE
BITARTRATE
|
N022466
|
INJECTABLE
|
|
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN;
DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE;
TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
|
N021265
|
INJECTABLE
|
|
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN;
DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE;
TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
|
N021646
|
INJECTABLE
|
|
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL;
FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN
5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E
|
N018920
|
FOR SOLUTION
|
|
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL;
ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN
5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K
|
N021625
|
INJECTABLE
|
|
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL;
ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN
5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K
|
N021643
|
INJECTABLE
|
|
ASPIRIN
|
N200671
|
CAPSULE, EXTENDED RELEASE
|
|
ATROPINE
SULFATE
|
N021146
|
SOLUTION
|
|
ATROPINE SULFATE
|
N206289
|
SOLUTION/DROPS
|
|
ATROPINE SULFATE
|
N208151
|
SOLUTION/DROPS
|
|
ATROPINE SULFATE
|
N209260
|
SOLUTION
|
|
ATROPINE SULFATE; DIFENOXIN
HYDROCHLORIDE
|
N017744
|
TABLET
|
|
AURANOFIN
|
N018689
|
CAPSULE
|
|
AZELAIC ACID
|
N020428
|
CREAM
|
|
AZITHROMYCIN
|
N050693
|
FOR SUSPENSION
|
|
AZITHROMYCIN
|
N050810
|
SOLUTION/DROPS
|
|
AZTREONAM
|
N050632
|
INJECTABLE
|
|
BARIUM SULFATE
|
N208036
|
FOR SUSPENSION
|
|
BARIUM SULFATE
|
N208143
|
SUSPENSION
|
|
BARIUM SULFATE
|
N208844
|
PASTE
|
|
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
|
N208582
|
SOLUTION/DROPS
|
|
BENZOYL PEROXIDE; ERYTHROMYCIN
|
N050769
|
GEL
|
|
BENZYLPENICILLOYL POLYLYSINE
|
N050114
|
INJECTABLE
|
|
BETAINE
|
N020576
|
FOR SOLUTION
|
|
BETAXOLOL HYDROCHLORIDE
|
N019845
|
SUSPENSION/DROPS
|
|
BEXAROTENE
|
N021056
|
GEL
|
|
BISMUTH
SUBCITRATE POTASSIUM; METRONIDAZOLE;
TETRACYCLINE
|
N050786
|
CAPSULE
|
|
BIVALIRUDIN
|
N208374
|
SOLUTION
|
|
BRINZOLAMIDE
|
N020816
|
SUSPENSION/DROPS
|
|
BUDESONIDE
|
N021949
|
POWDER, METERED
|
|
BUDESONIDE
|
N205613
|
AEROSOL, FOAM
|
|
BUPRENORPHINE
|
N021306
|
FILM, EXTENDED RELEASE
|
|
BUSULFAN
|
N009386
|
TABLET
|
|
BUTENAFINE HYDROCHLORIDE
|
N020524
|
CREAM
|
|
CALCIUM
CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM
CHLORIDE; SODIUM BICARBONATE; SODIUM
CHLORIDE;
SODIUM PHOSPHATE
|
N018469
|
SOLUTION
|
|
CALCIUM
CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;
SODIUM
BICARBONATE; SODIUM CHLORIDE
|
N021703
|
INJECTABLE
|
|
CALCIUM
CHLORIDE; DEXTROSE; MAGNESIUM
CHLORIDE;
SODIUM CHLORIDE; SODIUM LACTATE
|
N020183
|
SOLUTION
|
|
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE;
SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM
PHOSPHATE,
DIBASIC, HEPTAHYDRATE
|
N020577
|
INJECTABLE
|
|
CALCIUM
CHLORIDE; DEXTROSE; POTASSIUM
CHLORIDE;
SODIUM CHLORIDE; SODIUM LACTATE
|
N019367
|
INJECTABLE
|
|
CALCIUM
CHLORIDE; DEXTROSE; POTASSIUM
CHLORIDE;
SODIUM CHLORIDE; SODIUM LACTATE
|
N019634
|
INJECTABLE
|
|
CALCIUM
CHLORIDE; MAGNESIUM CHLORIDE;
POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
|
N018895
|
INJECTABLE
|
|
CALCIUM GLUCONATE
|
N208418
|
SOLUTION
|
|
CARBOPROST TROMETHAMINE
|
N017989
|
INJECTABLE
|
|
CARGLUMIC ACID
|
N022562
|
TABLET
|
|
CEFAZOLIN SODIUM
|
N050779
|
INJECTABLE
|
|
CEFAZOLIN SODIUM
|
N207131
|
SOLUTION
|
|
CEFEPIME HYDROCHLORIDE
|
N050817
|
INJECTABLE
|
|
CEFTAZIDIME
|
N050823
|
INJECTABLE
|
|
CHLORAMBUCIL
|
N010669
|
TABLET
|
|
CHLORDIAZEPOXIDE
HYDROCHLORIDE; CLIDINIUM
BROMIDE
|
N012750
|
CAPSULE
|
|
CHLOROPROCAINE HYDROCHLORIDE
|
N009435
|
INJECTABLE
|
|
CHLOROTHIAZIDE
|
N011870
|
SUSPENSION
|
|
CHROMIC CHLORIDE
|
N018961
|
INJECTABLE
|
|
CIPROFLOXACIN HYDROCHLORIDE
|
N020369
|
OINTMENT
|
|
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
|
N020805
|
SUSPENSION/DROPS
|
|
CITRIC
ACID; GLUCONOLACTONE; MAGNESIUM
CARBONATE
|
N019481
|
SOLUTION
|
|
CITRIC ACID; UREA C-13
|
N021314
|
FOR
SOLUTION, TABLET, FOR
SOLUTION
|
|
CLINDAMYCIN PHOSPHATE
|
N050635
|
INJECTABLE
|
|
CLINDAMYCIN PHOSPHATE
|
N208083
|
SOLUTION
|
|
CLINDAMYCIN PHOSPHATE; TRETINOIN
|
N050803
|
GEL
|
|
CLOCORTOLONE PIVALATE
|
N017765
|
CREAM
|
|
CLOZAPINE
|
N203479
|
SUSPENSION
|
|
CROTAMITON
|
N006927
|
CREAM
|
|
CUPRIC CHLORIDE
|
N018960
|
INJECTABLE
|
|
DALFOPRISTIN; QUINUPRISTIN
|
N050748
|
INJECTABLE
|
|
DALTEPARIN SODIUM
|
N020287
|
INJECTABLE
|
|
DAPTOMYCIN
|
N208385
|
POWDER
|
|
DAPTOMYCIN
|
N209949
|
POWDER
|
|
DECITABINE
|
N205582
|
POWDER
|
|
DELAVIRDINE MESYLATE
|
N020705
|
TABLET
|
|
DESVENLAFAXINE
|
N204150
|
TABLET, EXTENDED RELEASE
|
|
DESVENLAFAXINE
|
N204683
|
TABLET, EXTENDED RELEASE
|
|
DEXAMETHASONE;
TOBRAMYCIN
|
N050616
|
OINTMENT
|
|
DEXMEDETOMIDINE HYDROCHLORIDE
|
N206628
|
SOLUTION
|
|
DEXTROSE
|
N018562
|
INJECTABLE
|
|
DEXTROSE
|
N018564
|
INJECTABLE
|
|
DEXTROSE
|
N019345
|
INJECTABLE
|
|
DEXTROSE
|
N019445
|
INJECTABLE
|
|
DEXTROSE;
MAGNESIUM ACETATE; POTASSIUM
ACETATE;
SODIUM CHLORIDE
|
N017610
|
INJECTABLE
|
|
DEXTROSE;
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM
ACETATE
|
N019873
|
INJECTABLE
|
|
DEXTROSE;
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC;
SODIUM
CHLORIDE; SODIUM LACTATE
|
N017484
|
INJECTABLE
|
|
DEXTROSE;
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC;
SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC
ANHYDROUS
|
N019513
|
INJECTABLE
|
|
DEXTROSE;
MAGNESIUM CHLORIDE; POTASSIUM
CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
|
N017609
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE
|
N017634
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE
|
N018371
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
|
N018008
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
|
N018365
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
|
N018876
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
|
N019308
|
INJECTABLE
|
|
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
|
N019630
|
INJECTABLE
|
|
DEXTROSE; SODIUM CHLORIDE
|
N017606
|
INJECTABLE
|
|
DEXTROSE; SODIUM CHLORIDE
|
N017799
|
INJECTABLE
|
|
DEXTROSE;
SODIUM CHLORIDE
|
N019631
|
INJECTABLE
|
|
DIAZEPAM
|
N020648
|
GEL
|
|
DIAZOXIDE
|
N017453
|
SUSPENSION
|
|
DIGOXIN
|
N020405
|
TABLET
|
|
DIGOXIN
|
N021648
|
ELIXIR
|
|
DIHYDROERGOTAMINE MESYLATE
|
N020148
|
SPRAY, METERED
|
|
DIMERCAPROL
|
N005939
|
INJECTABLE
|
|
DINOPROSTONE
|
N017810
|
SUPPOSITORY
|
|
DINOPROSTONE
|
N019617
|
GEL
|
|
DINOPROSTONE
|
N020411
|
INSERT, EXTENDED RELEASE
|
|
DISOPYRAMIDE
PHOSPHATE
|
N018655
|
CAPSULE,
EXTENDED RELEASE
|
|
DOCETAXEL
|
N022234
|
INJECTABLE
|
|
DOCETAXEL
|
N203551
|
INJECTABLE
|
|
DOPAMINE HYDROCHLORIDE
|
N019099
|
INJECTABLE
|
|
DOPAMINE HYDROCHLORIDE
|
N019615
|
INJECTABLE
|
|
DOXAZOSIN MESYLATE
|
N021269
|
TABLET, EXTENDED RELEASE
|
|
DOXEPIN HYDROCHLORIDE
|
N020126
|
CREAM
|
|
DOXORUBICIN HYDROCHLORIDE
|
N050629
|
INJECTABLE
|
|
DOXYCYCLINE CALCIUM
|
N050480
|
SUSPENSION
|
|
DROSPIRENONE; ESTRADIOL
|
N021355
|
TABLET
|
|
ECHOTHIOPHATE
IODIDE
|
N011963
|
FOR SOLUTION
|
|
EDETATE CALCIUM DISODIUM
|
N008922
|
INJECTABLE
|
|
EFAVIRENZ;
LAMIVUDINE; TENOFOVIR DISOPROXIL
FUMARATE
|
N022142
|
TABLET
|
|
EFAVIRENZ;
LAMIVUDINE; TENOFOVIR DISOPROXIL
FUMARATE
|
N208255
|
TABLET
|
|
EFLORNITHINE HYDROCHLORIDE
|
N021145
|
CREAM
|
|
EMEDASTINE DIFUMARATE
|
N020706
|
SOLUTION/DROPS
|
|
ENFUVIRTIDE
|
N021481
|
INJECTABLE
|
|
ENTECAVIR
|
N021798
|
SOLUTION
|
|
EPINEPHRINE
|
N207534
|
SOLUTION
|
|
ESOMEPRAZOLE STRONTIUM
|
N202342
|
CAPSULE, DELAYED RELEASE
|
|
ESTRADIOL
|
N021674
|
FILM, EXTENDED RELEASE
|
|
ESTRADIOL
|
N022038
|
GEL
|
|
ESTRADIOL; NORETHINDRONE ACETATE
|
N020870
|
FILM, EXTENDED RELEASE
|
|
ESTRAMUSTINE PHOSPHATE SODIUM
|
N018045
|
CAPSULE
|
|
ESTROGENS, CONJUGATED
|
N004782
|
TABLET
|
|
ESTROGENS, CONJUGATED
|
N010402
|
INJECTABLE
|
|
ETHANOLAMINE OLEATE
|
N019357
|
INJECTABLE
|
|
ETHINYL ESTRADIOL; ETONOGESTREL
|
N021187
|
RING
|
|
ETHIONAMIDE
|
N013026
|
TABLET
|
|
ETOPOSIDE PHOSPHATE
|
N020457
|
INJECTABLE
|
|
FENOFIBRATE
|
N021612
|
CAPSULE
|
|
FENOPROFEN CALCIUM
|
N017604
|
CAPSULE
|
|
FLUORESCEIN SODIUM
|
N022186
|
INJECTABLE
|
|
FLUOROURACIL
|
N016988
|
CREAM
|
|
FLUTICASONE
PROPIONATE
|
N020833
|
POWDER
|
|
FOSAMPRENAVIR CALCIUM
|
N022116
|
SUSPENSION
|
|
FOSFOMYCIN TROMETHAMINE
|
N050717
|
FOR SOLUTION
|
|
GEMCITABINE HYDROCHLORIDE
|
N209604
|
SOLUTION
|
|
HALCINONIDE
|
N017556
|
CREAM
|
|
HALCINONIDE
|
N017824
|
OINTMENT
|
|
HEPARIN SODIUM
|
N018916
|
INJECTABLE
|
|
HEPARIN SODIUM
|
N019339
|
INJECTABLE
|
|
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
|
N021956
|
TABLET, EXTENDED RELEASE
|
|
HYDROCHLOROTHIAZIDE;
SPIRONOLACTONE
|
N012616
|
TABLET
|
|
HYDROCORTISONE ACETATE
|
N017351
|
AEROSOL, METERED
|
|
HYDROXYAMPHETAMINE
HYDROBROMIDE;
TROPICAMIDE
|
N019261
|
SOLUTION/DROPS
|
|
HYDROXYUREA
|
N016295
|
CAPSULE
|
|
ILOPROST
|
N021779
|
SOLUTION
|
|
INDOMETHACIN
|
N022536
|
INJECTABLE
|
|
IOBENGUANE SULFATE I-123
|
N022290
|
SOLUTION
|
|
IODIXANOL
|
N020351
|
INJECTABLE
|
|
IOFLUPANE I-123
|
N022454
|
SOLUTION
|
|
IRON DEXTRAN
|
N017441
|
INJECTABLE
|
|
IRON SUCROSE
|
N021135
|
INJECTABLE
|
|
ISOCARBOXAZID
|
N011961
|
TABLET
|
|
KETOROLAC TROMETHAMINE
|
N022382
|
SPRAY, METERED
|
|
LAMIVUDINE
|
N021004
|
SOLUTION
|
|
LAMIVUDINE; TENOFOVIR DISOPROXIL
FUMARATE
|
N022141
|
TABLET
|
|
LEFLUNOMIDE
|
N020905
|
TABLET
|
|
LEUPROLIDE ACETATE
|
N019732
|
INJECTABLE
|
|
LEUPROLIDE ACETATE
|
N020011
|
INJECTABLE
|
|
LEUPROLIDE ACETATE
|
N020263
|
INJECTABLE
|
|
LEUPROLIDE ACETATE
|
N020517
|
INJECTABLE
|
|
LEUPROLIDE ACETATE
|
N020708
|
INJECTABLE
|
|
LEUPROLIDE ACETATE; NORETHINDRONE
ACETATE
|
N203696
|
INJECTABLE, TABLET
|
|
LEVOLEUCOVORIN CALCIUM
|
N208723
|
POWDER
|
|
LEVOTHYROXINE SODIUM
|
N206977
|
SOLUTION
|
|
LEVOTHYROXINE SODIUM
|
N021924
|
CAPSULE
|
|
L-GLUTAMINE
|
N021667
|
FOR SOLUTION
|
|
LINEZOLID
|
N206473
|
SOLUTION
|
|
LODOXAMIDE TROMETHAMINE
|
N020191
|
SOLUTION/DROPS
|
|
LOMUSTINE
|
N017588
|
CAPSULE
|
|
LOTEPREDNOL ETABONATE
|
N020803
|
SUSPENSION/DROPS
|
|
LOTEPREDNOL ETABONATE
|
N200738
|
OINTMENT
|
|
LOTEPREDNOL ETABONATE; TOBRAMYCIN
|
N050804
|
SUSPENSION/DROPS
|
|
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE,
MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE,
DIBASIC, HEPTAHYDRATE
|
N019696
|
INJECTABLE
|
|
MAGNESIUM
CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE
|
N017378
|
INJECTABLE
|
|
MAGNESIUM
CHLORIDE; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
|
N017586
|
INJECTABLE
|
|
MAGNESIUM
CHLORIDE; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
|
N017637
|
SOLUTION
|
|
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
|
N019024
|
SOLUTION
|
|
MAGNESIUM
CHLORIDE; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
|
N019711
|
INJECTABLE
|
|
MAGNESIUM
CHLORIDE; SODIUM BICARBONATE;
SODIUM
CHLORIDE
|
N021910
|
SOLUTION
|
|
MAGNESIUM SULFATE
|
N019316
|
SOLUTION
|
|
MAGNESIUM SULFATE
|
N020488
|
INJECTABLE
|
|
MANGANESE
CHLORIDE
|
N018962
|
INJECTABLE
|
|
MEDROXYPROGESTERONE ACETATE
|
N012541
|
INJECTABLE
|
|
MEROPENEM
|
N202106
|
POWDER
|
|
MESALAMINE
|
N020049
|
CAPSULE, EXTENDED RELEASE
|
|
MESNA
|
N020855
|
TABLET
|
|
METHACHOLINE CHLORIDE
|
N019193
|
FOR SOLUTION
|
|
METHOHEXITAL SODIUM
|
N011559
|
INJECTABLE
|
|
METHSUXIMIDE
|
N010596
|
CAPSULE
|
|
METRONIDAZOLE
|
N020743
|
CREAM
|
|
METYROSINE
|
N017871
|
CAPSULE
|
|
MITOTANE
|
N016885
|
TABLET
|
|
MOMETASONE FUROATE
|
N021067
|
POWDER
|
|
MOMETASONE FUROATE
|
N205641
|
AEROSOL, METERED
|
|
MORPHINE SULFATE
|
N019916
|
INJECTABLE
|
|
MORPHINE SULFATE
|
N020616
|
CAPSULE, EXTENDED RELEASE
|
|
MORPHINE SULFATE
|
N022207
|
TABLET
|
|
MORPHINE SULFATE
|
N202515
|
INJECTABLE
|
|
MOXIFLOXACIN HYDROCHLORIDE
|
N205572
|
SOLUTION
|
|
NABILONE
|
N018677
|
CAPSULE
|
|
NAFCILLIN SODIUM
|
N050655
|
INJECTABLE
|
|
NELARABINE
|
N021877
|
INJECTABLE
|
|
NELFINAVIR MESYLATE
|
N020779
|
TABLET
|
|
NELFINAVIR MESYLATE
|
N021503
|
TABLET
|
|
NEOSTIGMINE METHYLSULFATE
|
N203629
|
SOLUTION
|
|
NICOTINE
|
N020385
|
SPRAY, METERED
|
|
NITAZOXANIDE
|
N021497
|
TABLET
|
|
NITAZOXANIDE
|
N021498
|
FOR SUSPENSION
|
|
NITISINONE
|
N209449
|
TABLET
|
|
NITROGLYCERIN
|
N020145
|
FILM, EXTENDED RELEASE
|
|
NITROGLYCERIN
|
N021780
|
AEROSOL, METERED
|
|
OCTREOTIDE ACETATE
|
N021008
|
INJECTABLE
|
|
OLANZAPINE PAMOATE
|
N022173
|
SUSPENSION, EXTENDED RELEASE
|
|
OLSALAZINE SODIUM
|
N019715
|
CAPSULE
|
|
ORLISTAT
|
N020766
|
CAPSULE
|
|
OXACILLIN SODIUM
|
N050640
|
INJECTABLE
|
|
OXICONAZOLE NITRATE
|
N020209
|
LOTION
|
|
OXYMETHOLONE
|
N016848
|
TABLET
|
|
PALONOSETRON
HYDROCHLORIDE
|
N207963
|
SOLUTION
|
|
PALONOSETRON HYDROCHLORIDE
|
N208109
|
SOLUTION
|
|
PENICILLAMINE
|
N019853
|
CAPSULE
|
|
PENICILLAMINE
|
N019854
|
TABLET
|
|
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
|
N050138
|
INJECTABLE
|
|
PENICILLIN G POTASSIUM
|
N050638
|
INJECTABLE
|
|
PENTAMIDINE ISETHIONATE
|
N019887
|
FOR SOLUTION
|
|
PENTETATE CALCIUM TRISODIUM
|
N021749
|
SOLUTION
|
|
PENTETATE ZINC TRISODIUM
|
N021751
|
SOLUTION
|
|
PENTOSAN
POLYSULFATE SODIUM
|
N020193
|
CAPSULE
|
|
PODOFILOX
|
N020529
|
GEL
|
|
POLIDOCANOL
|
N021201
|
SOLUTION
|
|
POLYETHYLENE
GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM
SULFATE
ANHYDROUS
|
N019011
|
FOR SOLUTION
|
|
POTASSIUM CHLORIDE
|
N019904
|
INJECTABLE
|
|
POVIDONE-IODINE
|
N018634
|
SOLUTION/DROPS
|
|
PRALIDOXIME CHLORIDE
|
N014134
|
INJECTABLE
|
|
PRALIDOXIME CHLORIDE
|
N018986
|
INJECTABLE
|
|
PROCARBAZINE HYDROCHLORIDE
|
N016785
|
CAPSULE
|
|
PROGESTERONE
|
N020701
|
GEL
|
|
PYRIMETHAMINE
|
N008578
|
TABLET
|
|
RABEPRAZOLE SODIUM
|
N204736
|
CAPSULE, DELAYED RELEASE
|
|
RIFAPENTINE
|
N021024
|
TABLET
|
|
RITONAVIR
|
N020659
|
SOLUTION
|
|
SALMETEROL XINAFOATE
|
N020692
|
POWDER
|
|
SAQUINAVIR MESYLATE
|
N021785
|
TABLET
|
|
SELEGILINE
|
N021336
|
FILM, EXTENDED RELEASE
|
|
SELEGILINE HYDROCHLORIDE
|
N021479
|
TABLET, ORALLY DISINTEGRATING
|
|
SILDENAFIL CITRATE
|
N203109
|
FOR SUSPENSION
|
|
SODIUM ACETATE
|
N018893
|
INJECTABLE
|
|
SODIUM CHLORIDE
|
N018897
|
INJECTABLE
|
|
SODIUM CHLORIDE
|
N019319
|
SOLUTION FOR SLUSH
|
|
SODIUM CHLORIDE
|
N019635
|
INJECTABLE
|
|
SODIUM CHLORIDE
|
N021569
|
INJECTABLE
|
|
SODIUM CHLORIDE
|
N202832
|
INJECTABLE
|
|
SODIUM
IODIDE I-131
|
N021305
|
CAPSULE
|
|
SODIUM IODIDE I-131
|
N021305
|
SOLUTION
|
|
SODIUM LACTATE
|
N018947
|
INJECTABLE
|
|
SODIUM NITROPRUSSIDE
|
N209387
|
SOLUTION
|
|
SODIUM
PHOSPHATE, DIBASIC, HEPTAHYDRATE;
SODIUM
PHOSPHATE, MONOBASIC, ANHYDROUS
|
N018892
|
INJECTABLE
|
|
SORBITOL
|
N016741
|
SOLUTION
|
|
SORBITOL
|
N017863
|
SOLUTION
|
|
SOTALOL HYDROCHLORIDE
|
N022306
|
SOLUTION
|
|
STREPTOZOCIN
|
N050577
|
INJECTABLE
|
|
SUCCIMER
|
N019998
|
CAPSULE
|
|
SUCRALFATE
|
N019183
|
SUSPENSION
|
|
TACROLIMUS
|
N204096
|
CAPSULE, EXTENDED RELEASE
|
|
TALC
|
N020587
|
AEROSOL
|
|
TAMOXIFEN CITRATE
|
N021807
|
SOLUTION
|
|
TAZAROTENE
|
N020600
|
GEL
|
|
TAZAROTENE
|
N021184
|
CREAM
|
|
TECHNETIUM TC-99M EXAMETAZIME KIT
|
N019829
|
INJECTABLE
|
|
TECHNETIUM TC-99M PENTETATE KIT
|
N018511
|
INJECTABLE
|
|
TESTOSTERONE
|
N020489
|
FILM, EXTENDED RELEASE
|
|
TETRACAINE
HYDROCHLORIDE
|
N208135
|
SOLUTION
|
|
THEOPHYLLINE
|
N019826
|
INJECTABLE
|
|
THIOGUANINE
|
N012429
|
TABLET
|
|
TIGECYCLINE
|
N208744
|
POWDER
|
|
TIOPRONIN
|
N019569
|
TABLET
|
|
TRAMADOL HYDROCHLORIDE
|
N022370
|
CAPSULE, EXTENDED RELEASE
|
|
TRETINOIN
|
N020475
|
GEL
|
|
TRIAMCINOLONE HEXACETONIDE
|
N016466
|
INJECTABLE
|
|
TRIAMTERENE
|
N013174
|
CAPSULE
|
|
TRIMETHOPRIM HYDROCHLORIDE
|
N074973
|
SOLUTION
|
|
TRIPTORELIN PAMOATE
|
N020715
|
INJECTABLE
|
|
TRIPTORELIN PAMOATE
|
N021288
|
INJECTABLE
|
|
VANCOMYCIN HYDROCHLORIDE
|
N050671
|
INJECTABLE
|
|
VANCOMYCIN HYDROCHLORIDE
|
N208910
|
FOR SOLUTION
|
|
VERAPAMIL HYDROCHLORIDE
|
N019614
|
CAPSULE, EXTENDED RELEASE
|
|
VERTEPORFIN
|
N021119
|
INJECTABLE
|
|
ZILEUTON
|
N020471
|
TABLET
|
|
ZIPRASIDONE MESYLATE
|
N020919
|
INJECTABLE
|
|
ZOLEDRONIC ACID
|
N204016
|
SOLUTION
|
Part II
|
Ingredient
|
Approved NDA
|
Dosage Form
|
|
ACETOHYDROXAMIC ACID
|
N018749
|
TABLET
|
|
ACYCLOVIR
|
N202408
|
OINTMENT
|
|
ALBUMIN IODINATED I-125 SERUM
|
N017836
|
INJECTABLE
|
|
ALBUMIN IODINATED I-131 SERUM
|
N017837
|
INJECTABLE
|
|
ALITRETINOIN
|
N020886
|
GEL
|
|
ALPROSTADIL
|
N020649
|
INJECTABLE
|
|
ALPROSTADIL
|
N021212
|
INJECTABLE
|
|
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE;
POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE;
SOYBEAN OIL
|
N200656
|
EMULSION
|
|
ATROPINE
|
N017106
|
SOLUTION
|
|
ATROPINE; PRALIDOXIME CHLORIDE
|
N021983
|
INJECTABLE
|
|
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
|
N019389
|
SPRAY, METERED
|
|
BERACTANT
|
N020032
|
SUSPENSION
|
|
CALCITRIOL
|
N022087
|
OINTMENT
|
|
CALFACTANT
|
N020521
|
SUSPENSION
|
|
CARMUSTINE
|
N020637
|
IMPLANT
|
|
CHLORHEXIDINE GLUCONATE
|
N020774
|
TABLET
|
|
CIPROFLOXACIN HYDROCHLORIDE
|
N021918
|
SOLUTION/DROPS
|
|
COLESTIPOL HYDROCHLORIDE
|
N017563
|
GRANULE
|
|
COLISTIN
SULFATE; HYDROCORTISONE ACETATE;
NEOMYCIN
SULFATE; THONZONIUM BROMIDE
|
N050356
|
SUSPENSION/DROPS
|
|
COPPER
|
N018680
|
INTRAUTERINE
DEVICE
|
|
CORTICORELIN OVINE TRIFLUTATE
|
N020162
|
INJECTABLE
|
|
CORTICOTROPIN
|
N008372
|
INJECTABLE
|
|
CYSTEAMINE BITARTRATE
|
N020392
|
CAPSULE
|
|
DESMOPRESSIN ACETATE
|
N020355
|
SPRAY, METERED
|
|
DIATRIZOATE MEGLUMINE
|
N010040
|
SOLUTION
|
|
DOXYCYCLINE HYCLATE
|
N050751
|
SYSTEM, EXTENDED RELEASE
|
|
ESTRADIOL
|
N020472
|
INSERT, EXTENDED RELEASE
|
|
ESTRADIOL
|
N020655
|
FILM, EXTENDED RELEASE
|
|
ESTRADIOL
|
N021166
|
GEL, METERED
|
|
ESTRADIOL
ACETATE
|
N021367
|
INSERT,
EXTENDED RELEASE
|
|
ESTRADIOL; LEVONORGESTREL
|
N021258
|
FILM, EXTENDED RELEASE
|
|
ESTROGENS, CONJUGATED
|
N020216
|
CREAM
|
|
ESTROGENS,
CONJUGATED; MEDROXYPROGESTERONE
ACETATE
|
N020527
|
TABLET
|
|
ETHOTOIN
|
N010841
|
TABLET
|
|
FERRIC HEXACYANOFERRATE(II)
|
N021626
|
CAPSULE
|
|
FLUNISOLIDE
|
N021247
|
AEROSOL, METERED
|
|
FLUOCINOLONE ACETONIDE
|
N020001
|
SHAMPOO
|
|
FLUOCINOLONE ACETONIDE
|
N021737
|
IMPLANT
|
|
FLUOROMETHOLONE
|
N017760
|
OINTMENT
|
|
FLUOROMETHOLONE
|
N019216
|
SUSPENSION/DROPS
|
|
FLUOROMETHOLONE ACETATE
|
N019079
|
SUSPENSION/DROPS
|
|
FLURANDRENOLIDE
|
N012806
|
CREAM
|
|
FLURANDRENOLIDE
|
N016455
|
TAPE
|
|
FOLLITROPIN ALFA/BETA
|
N021765
|
INJECTABLE
|
|
GADOBENATE DIMEGLUMINE
|
N021357
|
INJECTABLE
|
|
GADOBENATE DIMEGLUMINE
|
N021358
|
INJECTABLE
|
|
GADOBUTROL
|
N201277
|
SOLUTION
|
|
GADODIAMIDE
|
N020123
|
INJECTABLE
|
|
GADODIAMIDE
|
N022066
|
INJECTABLE
|
|
GADOPENTETATE DIMEGLUMINE
|
N019596
|
INJECTABLE
|
|
GADOPENTETATE DIMEGLUMINE
|
N021037
|
INJECTABLE
|
|
GADOTERIDOL
|
N020131
|
INJECTABLE
|
|
GADOTERIDOL
|
N021489
|
INJECTABLE
|
|
GALLIUM CITRATE GA-67
|
N017478
|
INJECTABLE
|
|
GALLIUM CITRATE GA-67
|
N018058
|
INJECTABLE
|
|
GANCICLOVIR
|
N022211
|
GEL
|
|
GENTAMICIN SULFATE; PREDNISOLONE
ACETATE
|
N050586
|
SUSPENSION/DROPS
|
|
GENTAMICIN SULFATE; PREDNISOLONE
ACETATE
|
N050612
|
OINTMENT
|
|
GLUCAGON
|
N020928
|
INJECTABLE
|
|
GLUCAGON HYDROCHLORIDE
|
N020918
|
INJECTABLE
|
|
GLUCAGON HYDROCHLORIDE
|
N201849
|
POWDER
|
|
GONADOTROPIN, CHORIONIC
|
N017016
|
INJECTABLE
|
|
GUAIFENESIN; HYDROCODONE BITARTRATE
|
N208085
|
TABLET
|
|
GUANIDINE HYDROCHLORIDE
|
N001546
|
TABLET
|
|
HISTRELIN ACETATE
|
N021732
|
IMPLANT
|
|
HYALURONIDASE
|
N021640
|
INJECTABLE
|
|
HYALURONIDASE
|
N021665
|
INJECTABLE
|
|
HYDROCORTISONE
ACETATE; NEOMYCIN SULFATE;
POLYMYXIN
B SULFATE
|
N050218
|
CREAM
|
|
HYDROCORTISONE PROBUTATE
|
N020453
|
CREAM
|
|
HYDROXOCOBALAMIN
|
N022041
|
INJECTABLE
|
|
HYDROXYPROPYL CELLULOSE
|
N018771
|
INSERT
|
|
ICODEXTRIN
|
N021321
|
SOLUTION
|
|
IMIGLUCERASE
|
N020367
|
INJECTABLE
|
|
INDIUM IN-111 CHLORIDE
|
N019841
|
INJECTABLE
|
|
INDIUM
IN-111 CHLORIDE
|
N019862
|
INJECTABLE
|
|
INDIUM IN-111 PENTETATE DISODIUM
|
N017707
|
INJECTABLE
|
|
INDIUM IN-111 PENTETREOTIDE KIT
|
N020314
|
INJECTABLE
|
|
INSULIN
ASPART PROTAMINE RECOMBINANT; INSULIN
ASPART
RECOMBINANT
|
N021172
|
INJECTABLE
|
|
INSULIN ASPART RECOMBINANT
|
N020986
|
INJECTABLE
|
|
INSULIN GLARGINE
|
N205692
|
SOLUTION
|
|
INSULIN HUMAN
|
N018780
|
SOLUTION
|
|
INSULIN LISPRO
|
N209196
|
SOLUTION
|
|
INSULIN
LISPRO PROTAMINE RECOMBINANT; INSULIN
LISPRO
RECOMBINANT
|
N021017
|
INJECTABLE
|
|
INSULIN
LISPRO PROTAMINE RECOMBINANT; INSULIN
LISPRO
RECOMBINANT
|
N021018
|
INJECTABLE
|
|
INSULIN LISPRO RECOMBINANT
|
N020563
|
INJECTABLE
|
|
IOHEXOL
|
N018956
|
SOLUTION
|
|
IOHEXOL
|
N018956
|
INJECTABLE
|
|
IOHEXOL
|
N020608
|
SOLUTION
|
|
IOHEXOL
|
N205383
|
FOR SOLUTION
|
|
IOPROMIDE
|
N020220
|
INJECTABLE
|
|
IOPROMIDE
|
N021425
|
INJECTABLE
|
|
IOTHALAMATE MEGLUMINE
|
N013295
|
INJECTABLE
|
|
IOTHALAMATE MEGLUMINE
|
N017057
|
SOLUTION
|
|
IOTHALAMATE SODIUM I-125
|
N017279
|
INJECTABLE
|
|
IOVERSOL
|
N019710
|
INJECTABLE
|
|
IOVERSOL
|
N020923
|
INJECTABLE
|
|
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
|
N050705
|
TABLET
|
|
ISOSORBIDE DINITRATE
|
N019790
|
CAPSULE, EXTENDED RELEASE
|
|
LIDOCAINE; PRILOCAINE
|
N021451
|
GEL
|
|
LOVASTATIN
|
N021316
|
TABLET, EXTENDED RELEASE
|
|
MAFENIDE ACETATE
|
N016763
|
CREAM
|
|
MANNITOL
|
N016772
|
SOLUTION
|
|
MANNITOL
|
N022368
|
POWDER
|
|
MECASERMIN RECOMBINANT
|
N021839
|
INJECTABLE
|
|
MENOTROPINS (FSH;LH)
|
N021663
|
INJECTABLE
|
|
METHOXSALEN
|
N020969
|
INJECTABLE
|
|
METYRAPONE
|
N012911
|
CAPSULE
|
|
MINOCYCLINE HYDROCHLORIDE
|
N209269
|
TABLET, EXTENDED RELEASE
|
|
MORPHINE
SULFATE
|
N019999
|
INJECTABLE
|
|
MUPIROCIN
|
N050788
|
OINTMENT
|
|
NAFARELIN ACETATE
|
N019886
|
SPRAY, METERED
|
|
NATAMYCIN
|
N050514
|
SUSPENSION
|
|
NESIRITIDE RECOMBINANT
|
N020920
|
FOR SOLUTION
|
|
NICOTINE
|
N020714
|
INHALANT
|
|
NITROGLYCERIN
|
N021359
|
OINTMENT
|
|
OXYTOCIN
|
N018248
|
INJECTABLE
|
|
OXYTOCIN
|
N018261
|
INJECTABLE
|
|
PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE)
|
N022175
|
CAPSULE, DELAYED RELEASE
|
|
PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE)
|
N022523
|
CAPSULE,
DELAYED RELEASE
|
|
PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE)
|
N022542
|
TABLET
|
|
PEGADEMASE BOVINE
|
N019818
|
INJECTABLE
|
|
PEGAPTANIB SODIUM
|
N021756
|
INJECTABLE
|
|
PEGVISOMANT
|
N021106
|
INJECTABLE
|
|
PENICILLIN G BENZATHINE
|
N050141
|
INJECTABLE
|
|
POLIDOCANOL
|
N205098
|
SOLUTION
|
|
PORACTANT ALFA
|
N020744
|
SUSPENSION
|
|
PORFIMER SODIUM
|
N020451
|
INJECTABLE
|
|
PRAMLINTIDE ACETATE
|
N021332
|
INJECTABLE
|
|
PREDNISOLONE
ACETATE
|
N017100
|
SUSPENSION/DROPS
|
|
PREDNISOLONE ACETATE; SULFACETAMIDE
SODIUM
|
N012813
|
SUSPENSION
|
|
RUBIDIUM CHLORIDE RB-82
|
N019414
|
INJECTABLE
|
|
RUBIDIUM CHLORIDE RB-82
|
N202153
|
SOLUTION
|
|
SAMARIUM SM-153 LEXIDRONAM
PENTASODIUM
|
N020570
|
INJECTABLE
|
|
SECRETIN SYNTHETIC HUMAN
|
N021256
|
FOR SOLUTION
|
|
SERTACONAZOLE NITRATE
|
N021385
|
CREAM
|
|
SOMATROPIN
|
N019774
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N019640
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N019764
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N020280
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N020522
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N020604
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N021426
|
INJECTABLE
|
|
SOMATROPIN RECOMBINANT
|
N021597
|
INJECTABLE
|
|
SOYBEAN OIL
|
N019942
|
INJECTABLE
|
|
SULCONAZOLE NITRATE
|
N018737
|
CREAM
|
|
SULCONAZOLE NITRATE
|
N018738
|
SOLUTION
|
|
SUMATRIPTAN SUCCINATE
|
N208223
|
SOLUTION
|
|
TACROLIMUS
|
N210115
|
FOR SUSPENSION
|
|
TALC
|
N021388
|
POWDER
|
|
TECHNETIUM TC-99M ALBUMIN AGGREGATED
KIT
|
N017881
|
INJECTABLE
|
|
TECHNETIUM TC-99M BICISATE KIT
|
N020256
|
INJECTABLE
|
|
TECHNETIUM TC-99M DISOFENIN KIT
|
N018467
|
INJECTABLE
|
|
TECHNETIUM TC-99M EXAMETAZIME KIT
|
N208870
|
POWDER
|
|
TECHNETIUM TC-99M MEDRONATE
|
N018035
|
INJECTABLE
|
|
TECHNETIUM TC-99M MEDRONATE KIT
|
N018124
|
INJECTABLE
|
|
TECHNETIUM
TC-99M MERTIATIDE KIT
|
N019882
|
INJECTABLE
|
|
TECHNETIUM TC-99M OXIDRONATE KIT
|
N018321
|
INJECTABLE
|
|
TECHNETIUM TC-99M RED BLOOD CELL KIT
|
N019981
|
INJECTABLE
|
|
TECHNETIUM
TC-99M SODIUM PERTECHNETATE
GENERATOR
|
N017243
|
SOLUTION
|
|
TECHNETIUM
TC-99M SODIUM PERTECHNETATE
GENERATOR
|
N017771
|
SOLUTION
|
|
TECHNETIUM
TC-99M SODIUM PERTECHNETATE
GENERATOR
|
N202158
|
SOLUTION
|
|
TERCONAZOLE
|
N021735
|
CREAM
|
|
THYROTROPIN
ALFA
|
N020898
|
INJECTABLE
|
|
TOBRAMYCIN
|
N050555
|
OINTMENT
|
|
TRETINOIN
|
N020400
|
GEL
|
|
TRIMETHADIONE
|
N005856
|
TABLET
|
|
UREA, C-14
|
N020617
|
CAPSULE
|
|
VALRUBICIN
|
N020892
|
SOLUTION
|
|
VELAGLUCERASE ALFA
|
N022575
|
INJECTABLE
|
|
XENON XE-133
|
N017284
|
GAS
|
|
XENON XE-133
|
N018327
|
GAS
|
|
ZANAMIVIR
|
N021036
|
POWDER
|
|
ZINC ACETATE
|
N020458
|
CAPSULE
|
|
ZINC CHLORIDE
|
N018959
|
INJECTABLE
|
Appendix
|
Ingredient
|
Approved NDA
|
Dosage Form
|
|
ACYCLOVIR
|
N021478
|
CREAM
|
|
AMINOCAPROIC ACID
|
N015197
|
TABLET
|
|
ERYTHROMYCIN ETHYLSUCCINATE
|
N050207
|
GRANULE
|
|
HYDROXYPROGESTERONE CAPROATE
|
N021945
|
SOLUTION
|
|
LOTEPREDNOL ETABONATE
|
N020583
|
SUSPENSION/DROPS
|
|
METHYLPREDNISOLONE
|
N011153
|
TABLET
|
|
MIFEPRISTONE
|
N020687
|
TABLET
|
|
NAFTIFINE HYDROCHLORIDE
|
N019356
|
GEL
|
|
PYRIDOSTIGMINE BROMIDE
|
N015193
|
SYRUP
|
|
TOREMIFENE CITRATE
|
N020497
|
TABLET
|
|
VIGABATRIN
|
N020427
|
TABLET
|
Methodology1
1.
The
list is based on the Orange Book
Data Files, accessed April 12, 2019.
2.
The
list includes Orange
Book-listed drug products. The
list generally does not differentiate between different strengths of
a given drug product. However, we have
included a drug product of multiple strengths on the list
if there is not an approved ANDA
for one or more of the strengths (even if there is an approved ANDA for
one or more other strengths).
The Agency has
identified the corresponding
NDA numbers for drug products included on the list to assist
applicants with identification of
the correct
reference listed drug (RLD).
3. A given drug product is included on the list if:
4.
Each drug product and corresponding NDA number is then placed on either
Part I or Part II of the list based on the following
criteria:
a. Part I of the list identifies
those drug products for which FDA
could immediately accept an ANDA without prior discussion with the Agency.
b. Part II identifies drug products for which development and submission
of an ANDA could involve potential legal, regulatory or scientific issues that should be addressed with the Agency prior to considering
submission of an ANDA.
 |
1 FDA notes
that the methodology used to compile
the original list (posted
in June 2017) was updated in December 2017. Under the
updated methodology, the list is
organized based on drug products, not active ingredients. This means that an active and approved NDA
for a particular active ingredient and
dosage form will be included on the list if there are no approved
ANDAs for at least one drug product for
that active ingredient and dosage form approved in the NDA, even
if there are approved ANDAs
that reference a drug product in a different NDA with the same active
ingredient and dosage
form.
2 “Active and approved” means
that the NDA for the relevant drug
product is approved and listed in the
Orange Book, and is not identified as a “discontinued” product in the
Orange Book. If all approved NDAs
for a given drug product are identified as
“discontinued” in the Orange Book, that drug product is not included
on the list.
3 Drug products with only approved and Orange
Book-listed ANDAs but no Orange Book-listed NDAs are not included on the list.
5 Drug products that have at least one Orange Book-listed
patent or exclusivity are not included on the list.
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