| Product |
Company |
Generic name |
KEGG DRUG |
Neoral capsule, liquid filled 25 mg (NDA)
Neoral capsule, liquid filled 100 mg (NDA)
Neoral solution 100 mg/mL (NDA)
|
Novartis Pharmaceuticals Corporation |
cyclosporine |
D00184
|
ATACAND tablet 4 mg (NDA)
ATACAND tablet 8 mg (NDA)
ATACAND tablet 16 mg (NDA)
ATACAND tablet 32 mg (NDA)
|
ANI Pharmaceuticals, Inc. |
Candesartan Cilexetil |
D00626
|
AZACTAM injection, powder, for solution 1 g (NDA)
AZACTAM injection, powder, for solution 2 g (NDA)
|
E.R. Squibb & Sons, L.L.C. |
AZTREONAM |
D00240
|
AMOXICILLIN powder, for suspension 125 mg/5mL (ANDA)
AMOXICILLIN powder, for suspension 250 mg/5mL (ANDA)
|
Chartwell RX, LLC |
Amoxicillin |
D00229
|
Vancocin capsule 125 mg (NDA)
Vancocin capsule 250 mg (NDA)
|
ANI Pharmaceuticals, Inc. |
vancomycin hydrochloride |
D00926
|
|
Cholestyramine powder, for suspension 4 g/9g (ANDA)
|
Ajanta Pharma USA Inc. |
Cholestyramine |
D02690
|
|
Dicyclomine tablet 20 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Dicyclomine hydrochloride |
D00717
|
|
Midazolam Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Jvet Pharmaceuticals LLC |
Midazolam Hydrochloride |
D00696
|
Carvedilol Phosphate capsule, extended release 10 mg (ANDA)
Carvedilol Phosphate capsule, extended release 20 mg (ANDA)
Carvedilol Phosphate capsule, extended release 40 mg (ANDA)
Carvedilol Phosphate capsule, extended release 80 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Carvedilol Phosphate |
D03415
|
Hydrocodone Bitartrate and Ibuprofen tablet 2.5 mg (ANDA)
Hydrocodone Bitartrate and Ibuprofen tablet 10 mg (ANDA)
Hydrocodone Bitartrate and Ibuprofen tablet 7.5 mg (ANDA)
Hydrocodone Bitartrate and Ibuprofen tablet 5 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Hydrocodone Bitartrate and Ibuprofen |
D02152
|
Acyclovir tablet 400 mg (ANDA)
Acyclovir tablet 800 mg (ANDA)
|
Cadila Pharmaceuticals Limited |
Acyclovir |
D00222
|
HERZUMA injection, powder, lyophilized, for solution 150 mg/7.15mL (BLA)
HERZUMA kit (BLA)
|
Cephalon, Inc. |
TRASTUZUMAB |
D03257
|
|
Atenolol tablet 50 mg (ANDA)
|
QPharma, Inc. |
Atenolol |
D00235
|
Candesartan Cilexetil and Hydrochlorothiazide tablet 16 mg (NDA AUTHORIZED GENERIC)
Candesartan Cilexetil and Hydrochlorothiazide tablet 32 mg (NDA AUTHORIZED GENERIC)
|
ANI Pharmaceuticals, Inc. |
Candesartan Cilexetil and Hydrochlorothiazide |
D09196
|
Rosuvastatin Calcium tablet 5 mg (ANDA)
Rosuvastatin Calcium tablet 10 mg (ANDA)
Rosuvastatin Calcium tablet 20 mg (ANDA)
Rosuvastatin Calcium tablet 40 mg (ANDA)
|
NorthStar Rx, LLC |
Rosuvastatin Calcium |
D01915
|
|
Lisinopril and Hydrochlorothiazide tablet 12.5 mg (ANDA)
|
QPharma, Inc. |
Lisinopril and Hydrochlorothiazide |
D10268
|
|
Losartan Potassium tablet, film coated 25 mg (ANDA)
|
QPharma, Inc. |
Losartan Potassium |
D00357
|
|
Losartan Potassium tablet, film coated 50 mg (ANDA)
|
QPharma, Inc. |
Losartan Potassium |
D00357
|
Xanax XR tablet, extended release .5 mg (NDA)
Xanax XR tablet, extended release 1 mg (NDA)
Xanax XR tablet, extended release 2 mg (NDA)
Xanax XR tablet, extended release 3 mg (NDA)
|
Viatris Specialty LLC |
alprazolam |
D00225
|
|
Terbinafine tablet 250 mg (ANDA)
|
REMEDYREPACK INC. |
Terbinafine |
D02219
|
Metformin Hydrochloride tablet, film coated, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated, extended release 1000 mg (ANDA)
|
Micro Labs Limited |
Metformin Hydrochloride |
D00944
|
|
Sandostatin LAR Depot kit (NDA)
|
Novartis Pharmaceuticals Corporation |
octreotide acetate |
D06495
|
Nicardipine Hydrochloride capsule 20 mg (ANDA)
Nicardipine Hydrochloride capsule 30 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Nicardipine Hydrochloride |
D00617
|
|
ILLUCCIX kit (NDA)
|
Telix Pharmaceuticals (US) Inc. |
Kit for the preparation of gallium Ga 68 gozetotide injection |
D12257
|
ATACAND HCT tablet 16 mg (NDA)
ATACAND HCT tablet 32 mg (NDA)
|
ANI Pharmaceuticals, Inc. |
Candesartan Cilexetil and Hydrochlorothiazide |
D09196
|
|
Travoprost ophthalmic solution solution/ drops .04 mg/mL (ANDA)
|
Alembic Pharmaceuticals Limited |
Travoprost ophthalmic |
D01964
|
|
PROCHLORPERAZINE MALEATE tablet 10 mg (ANDA)
|
QPharma, Inc. |
Prochlorperazine maleate |
D00479
|
|
Gazyva injection, solution, concentrate 1000 mg/40mL (BLA)
|
Genentech, Inc. |
obinutuzumab |
D09321
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 325 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 325 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
COPIKTRA capsule 15 mg (NDA)
COPIKTRA capsule 25 mg (NDA)
|
Secura Bio, Inc |
duvelisib |
D11658
|
oxybutynin chloride tablet, extended release 5 mg (ANDA)
oxybutynin chloride tablet, extended release 10 mg (ANDA)
oxybutynin chloride tablet, extended release 15 mg (ANDA)
|
Chartwell RX, LLC |
OXYBUTYNIN CHLORIDE |
D00722
|
Ethambutol Hydrochloride tablet, film coated 100 mg (NDA AUTHORIZED GENERIC)
Ethambutol Hydrochloride tablet, film coated 400 mg (NDA)
|
Kanchan Healthcare Inc |
Ethambutol Hydrochloride |
D00878
|
|
Lisinopril tablet 10 mg (ANDA)
|
QPharma, Inc. |
Lisinopril |
D00362
|
|
TNKase kit (BLA)
|
Genentech, Inc. |
tenecteplase |
D06070
|
|
Amoxicillin and Clavulanate Potassium powder, for suspension 600 mg/5mL (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Oziltus injection, solution 70 mg/mL (BLA)
|
Amneal Pharmaceuticals LLC |
denosumab-mobz |
D03684
|
|
Tobramycin solution 300 mg/5mL (ANDA)
|
American Health Packaging |
Tobramycin |
D00063
|
|
Protonix I.V. injection, powder, for solution 40 mg0mL (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
PANTOPRAZOLE SODIUM |
D02593
|
|
Lisinopril tablet 20 mg (ANDA)
|
QPharma, Inc. |
Lisinopril |
D00362
|