| Product |
Company |
Generic name |
KEGG DRUG |
|
Pramipexole Dihydrochloride tablet .75 mg (ANDA)
|
Bryant Ranch Prepack |
Pramipexole Dihydrochloride |
D00559
|
Rivastigmine patch, extended release 9.5 mg/24h (ANDA)
Rivastigmine patch, extended release 13.3 mg/24h (ANDA)
|
Northstar Rx LLC. |
Rivastigmine |
D03822
|
Rivastigmine patch, extended release 4.6 mg/24h (ANDA)
Rivastigmine patch, extended release 9.5 mg/24h (ANDA)
Rivastigmine patch, extended release 13.3 mg/24h (ANDA)
|
Zydus Lifesciences Limited |
Rivastigmine |
D03822
|
|
Pregabalin capsule 75 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Pregabalin |
D02716
|
Lamotrigine tablet, extended release 25 mg (ANDA)
Lamotrigine tablet, extended release 50 mg (ANDA)
Lamotrigine tablet, extended release 100 mg (ANDA)
Lamotrigine tablet, extended release 200 mg (ANDA)
Lamotrigine tablet, extended release 250 mg (ANDA)
Lamotrigine tablet, extended release 300 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Lamotrigine |
D00354
|
methylphenidate hydrochloride capsule, extended release 10 mg (ANDA)
methylphenidate hydrochloride capsule, extended release 15 mg (ANDA)
methylphenidate hydrochloride capsule, extended release 20 mg (ANDA)
methylphenidate hydrochloride capsule, extended release 30 mg (ANDA)
methylphenidate hydrochloride capsule, extended release 40 mg (ANDA)
methylphenidate hydrochloride capsule, extended release 50 mg (ANDA)
methylphenidate hydrochloride capsule, extended release 60 mg (ANDA)
|
Actavis Pharma, Inc. |
methylphenidate hydrochloride |
D01296
|
Dexlansoprazole capsule, delayed release 30 mg (ANDA)
Dexlansoprazole capsule, delayed release 60 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Dexlansoprazole |
D08903
|
|
HALOG solution 1 mg/mL (NDA)
|
Genus Lifesciences Inc. |
Halcinonide Topical |
D01308
|
Sacubitril and Valsartan tablet, film coated 24 mg (ANDA)
Sacubitril and Valsartan tablet, film coated 51 mg (ANDA)
Sacubitril and Valsartan tablet, film coated 97 mg (ANDA)
|
AvKARE |
Sacubitril and Valsartan |
D10226
|
|
Tamsulosin Hydrochloride capsule .4 mg (ANDA)
|
AvKARE |
TAMSULOSIN HYDROCHLORIDE |
D01024
|
Ketorolac Tromethamine injection, solution 15 mg/mL (ANDA)
Ketorolac Tromethamine injection, solution 30 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
Ketorolac Tromethamine |
D00813
|
TAZORAC cream .05 mg/g (NDA)
TAZORAC cream .1 mg/g (NDA)
|
Almirall, LLC |
tazarotene |
D01132
|
|
DEXAMETHASONE elixir .5 mg/5mL (ANDA)
|
Kanchan Healthcare Inc |
DEXAMETHASONE |
D00292
|
|
Liraglutide injection 6 mg/mL (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Liraglutide |
D06404
|
|
PIOGLITAZONE HYDROCHLORIDE tablet 45 mg (ANDA)
|
REMEDYREPACK INC. |
pioglitazone hydrochloride |
D00945
|
|
Amoxicillin capsule 500 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Amoxicillin |
D00229
|
ORENCIA injection, powder, lyophilized, for solution 250 mg5mL (BLA)
ORENCIA injection, solution 125 mg/mL (BLA)
ORENCIA injection, solution 50 mg/.4mL (BLA)
ORENCIA injection, solution 87.5 mg/.7mL (BLA)
|
E.R. Squibb & Sons, L.L.C. |
abatacept |
D03203
|
|
VIMIZIM injection, solution, concentrate 5 mg/5mL (BLA)
|
BioMarin Pharmaceutical Inc. |
elosulfase alfa |
D10333
|
MEROPENEM injection 500 mg/20mL (ANDA)
MEROPENEM injection 1 g/30mL (ANDA)
|
Sandoz Inc |
MEROPENEM |
D02222
|
|
Butalbital, aspirin, and caffeine capsule 50 mg (ANDA)
|
Sandoz Inc |
Butalbital, aspirin, and caffeine |
D11859
|
|
Trisenox injection, solution 2 mg/mL (NDA)
|
Cephalon, LLC |
Arsenic Trioxide |
D02106
|
Bethanechol Chloride tablet 5 mg (ANDA)
Bethanechol Chloride tablet 10 mg (ANDA)
Bethanechol Chloride tablet 25 mg (ANDA)
Bethanechol Chloride tablet 50 mg (ANDA)
|
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. |
Bethanechol Chloride |
D01000
|
|
Carmustine kit (ANDA)
|
KVK-Tech, Inc. |
Carmustine |
D00254
|
Diltiazem Hydrochloride tablet, film coated 30 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 60 mg (ANDA)
|
American Health Packaging |
Diltiazem Hydrochloride |
D00616
|
|
Atrovent HFA aerosol, metered 17 ug (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
ipratropium bromide |
D02212
|
Duloxetine Hydrochloride capsule, delayed release 20 mg (ANDA)
Duloxetine Hydrochloride capsule, delayed release 30 mg (ANDA)
Duloxetine Hydrochloride capsule, delayed release 60 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Duloxetine Hydrochloride |
D01179
|
Bupropion hydrochloride tablet, extended release 100 mg (ANDA)
Bupropion hydrochloride tablet, extended release 150 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Bupropion hydrochloride |
D00817
|
|
Dalbavancin injection, powder, for solution 500 mg/25mL (ANDA)
|
Teva Pharmaceuticals, Inc. |
Dalbavancin |
D13218
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
American Health Packaging |
Cyclobenzaprine |
D00772
|
|
Noxivent 102 gas 800 mg/L (ANDA)
|
Linde Gas & Equipment Inc |
Noxivent 102 |
D00074
|
|
PRAVASTATIN SODIUM tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
PRAVASTATIN SODIUM |
D00893
|
Quetiapine tablet, film coated 25 mg (ANDA)
Quetiapine tablet, film coated 50 mg (ANDA)
Quetiapine tablet, film coated 100 mg (ANDA)
Quetiapine tablet, film coated 200 mg (ANDA)
Quetiapine tablet, film coated 300 mg (ANDA)
Quetiapine tablet, film coated 400 mg (ANDA)
|
Accord Healthcare Inc. |
Quetiapine |
D00458
|
Micafungin injection, powder, lyophilized, for solution 50 mg/5mL (ANDA)
Micafungin injection, powder, lyophilized, for solution 100 mg/5mL (ANDA)
|
Sagent Pharmaceuticals |
Micafungin Sodium |
D02465
|
Nilotinib capsule 50 mg (NDA)
Nilotinib capsule 150 mg (NDA)
Nilotinib capsule 200 mg (NDA)
|
EXELAN PHARMACEUTICALS INC. |
Nilotinib |
D13008
|
|
NITROUS OXIDE gas 99 kg00kg (NDA)
|
Holston Gases, Inc |
NITROUS OXIDE |
D00102
|
QUETIAPINE FUMARATE tablet, extended release 400 mg (ANDA)
QUETIAPINE FUMARATE tablet, extended release 200 mg (ANDA)
QUETIAPINE FUMARATE tablet, extended release 300 mg (ANDA)
QUETIAPINE FUMARATE tablet, extended release 150 mg (ANDA)
|
Accord Healthcare Inc. |
QUETIAPINE FUMARATE |
D00458
|
Rosuvastatin tablet, film coated 5 mg (ANDA)
Rosuvastatin tablet, film coated 10 mg (ANDA)
Rosuvastatin tablet, film coated 20 mg (ANDA)
Rosuvastatin tablet, film coated 40 mg (ANDA)
|
Accord Healthcare Inc. |
Rosuvastatin |
D01915
|
|
Diclofenac Sodium Delayed Release tablet, delayed release 75 mg (ANDA)
|
PHOENIX RX LLC |
Diclofenac Sodium |
D00904
|
|
Loperamide Hydrochloride capsule 2 mg (ANDA)
|
American Health Packaging |
Loperamide Hydrochloride |
D00729
|
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
Major Pharmaceuticals |
Sevelamer Carbonate |
D06642
|