| Product |
Company |
Generic name |
KEGG DRUG |
Esomeprazole Magnesium capsule, delayed release pellets 20 mg (ANDA)
Esomeprazole Magnesium capsule, delayed release pellets 40 mg (ANDA)
|
Mylan Pharmaceuticals Inc.
|
Esomeprazole Magnesium
|
D01984
|
|
OXCARBAZEPINE tablet, film coated 600 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
OXCARBAZEPINE
|
D00533
|
Chlordiazepoxide Hydrochloride capsule, gelatin coated 5 mg (ANDA)
Chlordiazepoxide Hydrochloride capsule, gelatin coated 10 mg (ANDA)
Chlordiazepoxide Hydrochloride capsule, gelatin coated 25 mg (ANDA)
|
Solco Healthcare US LLC
|
Chlordiazepoxide Hydrochloride
|
D00693
|
|
GABAPENTIN capsule 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
GABAPENTIN
|
D00332
|
Neulasta injection 6 mg/.6mL (BLA)
Neulasta kit (BLA)
|
Amgen Inc
|
pegfilgrastim
|
D06889
|
|
Sulfasalazine tablet, delayed release 500 mg (NDA AUTHORIZED GENERIC)
|
Greenstone LLC
|
Sulfasalazine
|
D00448
|
|
calcipotriene aerosol, foam 50 ug/g (NDA)
|
Mayne Pharma
|
calcipotriene
|
D01125
|
|
Acetazolamide capsule, extended release 500 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
|
Acetazolamide
|
D00218
|
|
SIMLIYA kit (ANDA)
|
Aurobindo Pharma Limited
|
Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol
|
D04484
|
|
Sulfasalazine tablet 500 mg (NDA AUTHORIZED GENERIC)
|
Greenstone LLC
|
Sulfasalazine
|
D00448
|
|
THYQUIDITY solution 100 ug/5mL (NDA)
|
VistaPharm, Inc.
|
Levothyroxine Sodium
|
D01010
|
|
SEVELAMER CARBONATE tablet, film coated 800 mg (ANDA)
|
Vitruvias Therapeutics
|
SEVELAMER CARBONATE
|
D06642
|
|
Nylia 7/7/7 kit (ANDA)
|
Aurobindo Pharma Limited
|
Norethindrone and Ethinyl Estradiol
|
D04483
|
Tramadol Hydrochloride tablet, coated 50 mg (ANDA)
Tramadol Hydrochloride tablet, coated 100 mg (ANDA)
|
Advagen Pharma Limited
|
Tramadol Hydrochloride
|
D01355
|
|
Magnesium Sulfate injection, solution 40 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
Magnesium Sulfate Heptahydrate
|
D01108
|
|
THYQUIDITY solution 100 ug/5mL (NDA)
|
GALENICA S.A.
|
Levothyroxine Sodium
|
D01010
|
|
Kalliga kit (ANDA)
|
Aurobindo Pharma Limited
|
Desogestrel and Ethinyl Estradiol
|
D04484
|
pramipexole dihydrochloride tablet .125 mg (ANDA)
pramipexole dihydrochloride tablet .25 mg (ANDA)
pramipexole dihydrochloride tablet .5 mg (ANDA)
pramipexole dihydrochloride tablet .75 mg (ANDA)
pramipexole dihydrochloride tablet 1 mg (ANDA)
pramipexole dihydrochloride tablet 1.5 mg (ANDA)
|
Strides Pharma Science Limited
|
pramipexole dihydrochloride
|
D00559
|
|
Ezetimibe tablet 10 mg (ANDA)
|
ScieGen Pharmaceuticals Inc
|
Ezetimibe
|
D01966
|
Tramadol Hydrochloride tablet, coated 50 mg (ANDA)
Tramadol Hydrochloride tablet, coated 100 mg (ANDA)
|
TRUPHARMA LLC
|
Tramadol Hydrochloride
|
D01355
|
|
Zoledronic Acid injection, solution, concentrate 4 mg/5mL (ANDA)
|
Gland Pharma Limited
|
zoledronic acid
|
D01968
|
|
Tobramycin injection 40 mg/mL (ANDA)
|
Gland Pharma Limited
|
Tobramycin
|
D02542
|
Plegridy Pen injection, solution 125 ug/.5mL (BLA)
Plegridy injection, solution 125 ug/.5mL (BLA)
|
Biogen Inc.
|
peginterferon beta-1a
|
D10483
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 10 mg (ANDA)
|
Bryant Ranch Prepack
|
Hydrocodone Bitartrate and Acetaminophen
|
D00846
|
Lamotrigine tablet 25 mg (ANDA)
Lamotrigine tablet 100 mg (ANDA)
Lamotrigine tablet 150 mg (ANDA)
Lamotrigine tablet 200 mg (ANDA)
|
JUBILANT CADISTA PHARMACEUTICALS INC.
|
Lamotrigine
|
D00354
|
|
Azithromycin injection, powder, lyophilized, for solution 500 mg/5mL (ANDA)
|
Mylan Institutional LLC
|
azithromycin
|
D06390
|
|
Metoclopramide solution 5 mg/5mL (ANDA)
|
Bryant Ranch Prepack
|
Metoclopramide
|
D05008
|
LEVOFLOXACIN tablet 250 mg (ANDA)
LEVOFLOXACIN tablet 500 mg (ANDA)
LEVOFLOXACIN tablet 750 mg (ANDA)
|
Torrent Pharmaceuticals Limited
|
LEVOFLOXACIN
|
D00588
|
Simulect injection, powder, for solution 20 mg/5mL (BLA)
Simulect injection, powder, for solution 10 mg/2.5mL (BLA)
|
Novartis Pharmaceuticals Corporation
|
basiliximab
|
D03058
|
|
Labetalol HCL tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack
|
Labetalol Hydrochloride
|
D00600
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 5 mg (ANDA)
|
Bryant Ranch Prepack
|
Hydrocodone Bitartrate and Acetaminophen
|
D00846
|
|
Memantine Hydrochloride capsule, extended release 28 mg (ANDA)
|
Bryant Ranch Prepack
|
Memantine Hydrochloride
|
D04905
|
|
Venlafaxine tablet 75 mg (ANDA)
|
REMEDYREPACK INC.
|
Venlafaxine
|
D00821
|
|
Hydrocodone Bitartrate and Acetaminophen solution 7.5 mg5mL (ANDA)
|
Bryant Ranch Prepack
|
Hydrocodone Bitartrate and Acetaminophen
|
D00846
|
|
Enalapril Maleate tablet 10 mg (ANDA)
|
REMEDYREPACK INC.
|
Enalapril Maleate
|
D00621
|
|
Methadone Hydrochloride tablet 10 mg (ANDA)
|
Bryant Ranch Prepack
|
Methadone Hydrochloride
|
D02102
|
|
Sodium Chloride injection, solution 9 g000mL (ANDA)
|
Nextgen Pharmaceuticals LLC
|
SODIUM CHLORIDE
|
D02056
|
Afrezza powder, metered 4 1 (BLA)
Afrezza kit (BLA)
Afrezza powder, metered 8 1 (BLA)
Afrezza powder, metered 12 1 (BLA)
|
Mannkind Corporation
|
Insulin Human
|
D03230
|
|
Nayzilam spray 5 mg/.1mL (NDA)
|
UCB, Inc.
|
midazolam
|
D00696
|
|
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide syrup 2 mg/5mL (ANDA)
|
Bryant Ranch Prepack
|
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
|
D11647
|