| Product |
Company |
Generic name |
KEGG DRUG |
ACCOLATE tablet, film coated 10 mg (NDA)
ACCOLATE tablet, film coated 20 mg (NDA)
|
Strides Pharma Science Limited |
Zafirlukast |
D00411
|
|
Risperidone solution 1 mg/mL (ANDA)
|
Bryant Ranch Prepack |
Risperidone |
D00426
|
Clindamycin phosphate injection, solution 600 mg/50mL (ANDA)
Clindamycin phosphate injection, solution 900 mg/50mL (ANDA)
|
Baxter Healthcare Company |
Clindamycin phosphate |
D01073
|
|
Bromfenac Ophthalmic Solution, 0.07% solution/ drops .7 mg/mL (ANDA)
|
Apotex Corp. |
Bromfenac Sodium |
D03163
|
clindamycin phosphate injection, solution 300 mg/50mL (NDA)
clindamycin phosphate injection, solution 600 mg/50mL (NDA)
clindamycin phosphate injection, solution 900 mg/50mL (NDA)
|
Baxter Healthcare Company |
clindamycin phosphate |
D01073
|
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Heparin Sodium |
D02112
|
|
sirolimus solution 1 mg/mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
sirolimus |
D00753
|
|
CROMOLYN SODIUM solution, concentrate 100 mg/5mL (ANDA)
|
Bryant Ranch Prepack |
CROMOLYN SODIUM |
D00526
|
SOHONOS capsule 1 mg (NDA)
SOHONOS capsule 1.5 mg (NDA)
SOHONOS capsule 2.5 mg (NDA)
SOHONOS capsule 5 mg (NDA)
SOHONOS capsule 10 mg (NDA)
|
Ipsen Biopharmaceuticals, Inc. |
palovarotene |
D09365
|
|
DOXYCYCLINE injection, powder, lyophilized, for solution 100 mg0mL (ANDA)
|
Gland Pharma Limited |
DOXYCYCLINE |
D02129
|
|
MEKTOVI tablet, film coated 15 mg (NDA)
|
Array BioPharma Inc. |
BINIMETINIB |
D10604
|
|
Clonidine Hydrochloride tablet .2 mg (ANDA)
|
Bryant Ranch Prepack |
Clonidine Hydrochloride |
D00604
|
|
Naproxen tablet 375 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Naproxen |
D00118
|
Pioglitazone tablet 15 mg (ANDA)
Pioglitazone tablet 30 mg (ANDA)
|
Major Pharmaceuticals |
Pioglitazone |
D00945
|
|
Clonidine Hydrochloride tablet .2 mg (ANDA)
|
Bryant Ranch Prepack |
Clonidine Hydrochloride |
D00604
|
|
Meloxicam tablet 7.5 mg (ANDA)
|
Bryant Ranch Prepack |
Meloxicam |
D00969
|
Clindamycin phosphate injection, solution 300 mg/50mL (ANDA)
Clindamycin phosphate injection, solution 600 mg/50mL (ANDA)
Clindamycin phosphate injection, solution 900 mg/50mL (ANDA)
|
Baxter Healthcare Company |
Clindamycin phosphate |
D01073
|
Synjardy XR tablet, extended release 10 mg (NDA)
Synjardy XR tablet, extended release 5 mg (NDA)
Synjardy XR tablet, extended release 25 mg (NDA)
Synjardy XR tablet, extended release 12.5 mg (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
empagliflozin, metformin hydrochloride |
D10752
|
Rivastigmine patch 13.3 mg/24h (ANDA)
Rivastigmine patch 4.6 mg/24h (ANDA)
Rivastigmine patch 9.5 mg/24h (ANDA)
|
Amneal Pharmaceuticals LLC |
Rivastigmine |
D03822
|
|
Torisel kit (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
temsirolimus |
D06068
|
|
FLUZONE HD TIV SH 2025 injection, suspension 60 ug/.5mL (BLA)
|
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
|
Fluoxetine capsule 10 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 40 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Fluoxetine |
D00823
|
Doxycycline capsule 50 mg (ANDA)
Doxycycline capsule 100 mg (ANDA)
Doxycycline capsule 150 mg (ANDA)
|
Strides Pharma Science Limited |
doxycycline |
D00307
|
|
FABHALTA capsule 200 mg (NDA)
|
Novartis Pharmaceuticals Corporation |
iptacopan |
D12252
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 300 mg (ANDA)
|
Bryant Ranch Prepack |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.25 g (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.5 g (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Vancomycin Hydrochloride |
D00926
|
Lurasidone hydrochloride tablet, coated 60 mg (ANDA)
Lurasidone hydrochloride tablet, coated 20 mg (ANDA)
Lurasidone hydrochloride tablet, coated 40 mg (ANDA)
Lurasidone hydrochloride tablet, coated 80 mg (ANDA)
Lurasidone hydrochloride tablet, coated 120 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Lurasidone hydrochloride |
D04820
|
|
TYSABRI injection 300 mg5mL (BLA)
|
Biogen Inc. |
natalizumab |
D06886
|
|
Carboprost Tromethamine injection, solution 250 ug/mL (ANDA)
|
Dr. Reddy's Laboratories Inc. |
Carboprost Tromethamine |
D00682
|
|
ARSENIC TRIOXIDE injection, solution 1 mg/mL (ANDA)
|
Nordic Pharma, Inc. |
Arsenic Trioxide |
D02106
|
|
Octreotide Acetate kit (ANDA)
|
Teva Pharmaceuticals, Inc. |
Octreotide Acetate |
D06495
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
|
Bryant Ranch Prepack |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 300 mg (ANDA)
|
Bryant Ranch Prepack |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
Aripiprazole tablet, orally disintegrating 10 mg (ANDA)
Aripiprazole tablet, orally disintegrating 15 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Aripiprazole |
D01164
|
|
Escitalopram tablet, film coated 5 mg (ANDA)
|
American Health Packaging |
Escitalopram |
D02567
|
|
Eprontia solution 25 mg/mL (NDA)
|
Azurity Pharmaceuticals, Inc. |
Topiramate |
D00537
|
BELSOMRA tablet, film coated 5 mg (NDA)
BELSOMRA tablet, film coated 10 mg (NDA)
BELSOMRA tablet, film coated 15 mg (NDA)
BELSOMRA tablet, film coated 20 mg (NDA)
|
Merck Sharp & Dohme LLC |
suvorexant |
D10082
|
Ampicillin and Sulbactam injection, powder, for solution 1 g (ANDA)
Ampicillin and Sulbactam injection, powder, for solution 2 g (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Ampicillin sodium and Sulbactam sodium |
D02065
|
|
Lacosamide injection 10 mg/mL (ANDA)
|
Fosun Pharma USA |
Lacosamide |
D07299
|
Lubiprostone capsule, gelatin coated 8 ug (NDA AUTHORIZED GENERIC)
Lubiprostone capsule, gelatin coated 24 ug (NDA AUTHORIZED GENERIC)
|
Sun Pharmaceutical Industries, Inc. |
lubiprostone |
D04790
|