| Product |
Company |
Generic name |
KEGG DRUG |
|
Sirolimus solution 1 mg/mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
SIrolimus |
D00753
|
INVEGA TRINZA injection, suspension, extended release 273 mg/.88mL (NDA)
INVEGA TRINZA injection, suspension, extended release 410 mg.32mL (NDA)
INVEGA TRINZA injection, suspension, extended release 546 mg.75mL (NDA)
INVEGA TRINZA injection, suspension, extended release 819 mg/2.63mL (NDA)
|
Janssen Pharmaceuticals, Inc |
paliperidone palmitate |
D05340
|
|
Milrinone Lactate injection, solution 1 mg/mL (ANDA)
|
Caplin Steriles Limited |
Milrinone Lactate |
D02085
|
|
PANTOPRAZOLE SODIUM injection, powder, lyophilized, for solution 40 mg0mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
PANTOPRAZOLE SODIUM |
D02593
|
|
Haloperidol tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Haloperidol |
D00136
|
|
Clobetasol Propionate cream .25 mg/g (NDA AUTHORIZED GENERIC)
|
INA Pharmaceutics Inc |
clobetasol propionate |
D01272
|
|
HYDRALAZINE HYDROCHLORIDE tablet 50 mg (ANDA)
|
Coupler LLC |
hydralazine hydrochloride |
D01302
|
|
PRAVASTATIN SODIUM tablet 10 mg (ANDA)
|
Coupler LLC |
PRAVASTATIN SODIUM |
D00893
|
|
PRAVASTATIN SODIUM tablet 20 mg (ANDA)
|
Coupler LLC |
PRAVASTATIN SODIUM |
D00893
|
|
Isoniazid tablet 300 mg (ANDA)
|
Chartwell RX, LLC |
Isoniazid |
D00346
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
Ajanta Pharma USA Inc. |
ketorolac tromethamine |
D00813
|
|
Lacosamide injection 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Lacosamide |
D07299
|
ESTRADIOL tablet .5 mg (ANDA)
ESTRADIOL tablet 1 mg (ANDA)
ESTRADIOL tablet 2 mg (ANDA)
|
Asclemed USA, Inc. |
ESTRADIOL |
D00105
|
Paroxetine tablet, film coated 10 mg (ANDA)
Paroxetine tablet, film coated 20 mg (ANDA)
Paroxetine tablet, film coated 30 mg (ANDA)
Paroxetine tablet, film coated 40 mg (ANDA)
|
Asclemed USA, Inc. |
Paroxetine |
D02260
|
|
Omeprazole capsule, delayed release 10 mg (ANDA)
|
Chartwell RX, LLC |
Omeprazole |
D00455
|
|
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE spray, metered 137 ug (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
azelastine hydrochloride, fluticasone propionate |
D11656
|
|
Bupropion Hydrochloride tablet, extended release 300 mg (ANDA)
|
Asclemed USA, Inc. |
Bupropion Hydrochloride |
D00817
|
|
Triamcinolone Acetonide cream 1 mg/g (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Triamcinolone Acetonide |
D00983
|
|
Wixela Inhub powder 250 ug (ANDA)
|
Bryant Ranch Prepack |
fluticasone propionate and salmeterol |
D08699
|
|
Lacosamide Oral Solution solution 10 mg/mL (ANDA)
|
Chartwell RX, LLC |
Lacosamide |
D07299
|
Epinephrine injection .15 mg/.3mL (NDA AUTHORIZED GENERIC)
Epinephrine injection .3 mg/.3mL (NDA AUTHORIZED GENERIC)
|
Viatris Specialty LLC |
Epinephrine |
D00095
|
|
Phentermine Hydrochloride capsule 30 mg (ANDA)
|
Bryant Ranch Prepack |
phentermine hydrochloride |
D05459
|
|
Arformoterol Tartrate Inhalation Solution solution 15 ug/2mL (ANDA)
|
Aucta Pharmaceuticals, Inc. |
Arformoterol Tartrate |
D02981
|
Omeprazole capsule, delayed release 20 mg (ANDA)
Omeprazole capsule, delayed release 10 mg (ANDA)
Omeprazole capsule, delayed release 40 mg (ANDA)
|
Asclemed USA, Inc. |
Omeprazole |
D00455
|
|
Folic Acid tablet 1 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Folic Acid |
D00070
|
|
Valproic Acid capsule, liquid filled 250 mg (ANDA)
|
Bryant Ranch Prepack |
Valproic Acid |
D00399
|
|
SENSORCAINE MPF injection, solution 2.5 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE |
D11569
|
Selexipag tablet, film coated 200 ug (ANDA)
Selexipag tablet, film coated 400 ug (ANDA)
Selexipag tablet, film coated 600 ug (ANDA)
Selexipag tablet, film coated 800 ug (ANDA)
Selexipag tablet, film coated 1000 ug (ANDA)
Selexipag tablet, film coated 1200 ug (ANDA)
Selexipag tablet, film coated 1400 ug (ANDA)
Selexipag tablet, film coated 1600 ug (ANDA)
Selexipag TITRATION PACK kit (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
Selexipag |
D09994
|
|
Diclofenac Sodium Delayed Release tablet, delayed release 75 mg (ANDA)
|
Bryant Ranch Prepack |
Diclofenac Sodium |
D00904
|
Sertraline Hydrochloride tablet, film coated 25 mg (ANDA)
Sertraline Hydrochloride tablet, film coated 50 mg (ANDA)
Sertraline Hydrochloride tablet, film coated 100 mg (ANDA)
|
Asclemed USA, Inc. |
Sertraline Hydrochloride |
D00825
|
|
Lidocaine patch 50 mg/g (ANDA)
|
AVKARE |
Lidocaine |
D00358
|
|
Cephalexin capsule 500 mg (ANDA)
|
A-S Medication Solutions |
Cephalexin |
D00906
|
|
Dorzolamide Hydrochloride solution/ drops 20 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Dorzolamide Hydrochloride |
D00653
|
Eszopiclone tablet, film coated 2 mg (ANDA)
Eszopiclone tablet, film coated 1 mg (ANDA)
Eszopiclone tablet, film coated 3 mg (ANDA)
|
Asclemed USA, Inc. |
Eszopiclone |
D02624
|
Buspirone hydrochloride tablet 5 mg (ANDA)
Buspirone hydrochloride tablet 10 mg (ANDA)
Buspirone hydrochloride tablet 15 mg (ANDA)
Buspirone hydrochloride tablet 30 mg (ANDA)
Buspirone hydrochloride tablet 7.5 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Buspirone hydrochloride |
D00702
|
|
Clobetasol Propionate ointment .5 mg/g (ANDA)
|
Alembic Pharmaceuticals Limited |
Clobetasol Propionate |
D01272
|
|
budesonide capsule, coated pellets 3 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
budesonide |
D00246
|
|
ATORVASTATIN CALCIUM tablet, film coated 10 mg (ANDA)
|
Coupler LLC |
ATORVASTATIN CALCIUM |
D02258
|
Fluvoxamine maleate tablet 25 mg (ANDA)
Fluvoxamine maleate tablet 100 mg (ANDA)
|
Bionpharma Inc. |
Fluvoxamine maleate |
D00824
|
methimazole tablet 5 mg (ANDA)
methimazole tablet 10 mg (ANDA)
|
SQUARE PHARMACEUTICALS PLC. |
methimazole |
D00401
|