| Product |
Company |
Generic name |
KEGG DRUG |
Micafungin injection, powder, lyophilized, for solution 10 mg/mL (ANDA)
Micafungin injection, powder, lyophilized, for solution 20 mg/mL (ANDA)
|
Northstar Rx LLC. |
Micafungin |
D02465
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
REMEDYREPACK INC. |
Omeprazole |
D00455
|
|
Pregabalin capsule 75 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Pregabalin |
D02716
|
|
Citalopram tablet, film coated 20 mg (ANDA)
|
Bryant Ranch Prepack |
Citalopram |
D00822
|
|
metronidazole tablet 500 mg (ANDA)
|
REMEDYREPACK INC. |
metronidazole |
D00409
|
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
|
|
Benzonatate capsule 200 mg (ANDA)
|
REMEDYREPACK INC. |
Benzonatate |
D00242
|
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 49 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
|
Metronidazole tablet 250 mg (ANDA)
Metronidazole tablet 500 mg (ANDA)
|
Strides Pharma Science Limited |
Metronidazole |
D00409
|
|
TYRUKO injection 300 mg5mL (BLA)
|
Sandoz Inc |
natalizumab-sztn |
D06886
|
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
|
|
Isoproterenol hydrochloride injection, solution .2 mg/mL (ANDA)
|
KVK-Tech, Inc. |
Isoproterenol hydrochloride |
D01390
|
|
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
|
Dopamine Hydrochloride in Dextrose injection, solution 1.6 mg/mL (NDA)
Dopamine Hydrochloride in Dextrose injection, solution 3.2 mg/mL (NDA)
|
Hospira, Inc. |
Dopamine Hydrochloride in Dextrose |
D00633
|
|
VEVYE solution/ drops 1 mg/mL (NDA)
|
Harrow Eye, LLC |
cyclosporine ophthalmic solution |
D00184
|
|
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 325 mg (ANDA)
|
Sandoz Inc |
Butalbital, aspirin, and caffeine |
D11859
|
|
Trisenox injection, solution 2 mg/mL (NDA)
|
Cephalon, LLC |
Arsenic Trioxide |
D02106
|
|
Amoxicillin capsule 500 mg (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin |
D00229
|
|
ZYNYZ injection 25 mg/mL (BLA)
|
Incyte Corporation |
retifanlimab-dlwr |
D11827
|
|
VAXNEUVANCE injection, suspension 30 ug/.5mL (BLA)
|
Merck Sharp & Dohme LLC |
Pneumococcal 15-valent Conjugate Vaccine CRM197 Protein adsorbed |
D12205
|
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
|
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
|
REMEDYREPACK INC. |
Trazodone Hydrochloride |
D00820
|
Febuxostat tablet, film coated 40 mg (ANDA)
Febuxostat tablet, film coated 80 mg (ANDA)
|
Major Pharmaceuticals |
Febuxostat |
D11081
|
|
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
|
|
DOXIL injection, suspension, liposomal 2 mg/mL (NDA)
|
Baxter Healthcare Company |
doxorubicin hydrochloride |
D01275
|