| Product |
Company |
Generic name |
KEGG DRUG |
|
Clindamycin Phosphate and Benzoyl Peroxide kit (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clindamycin and Benzoyl Peroxide Gel |
D10602
|
|
polymyxin b sulfate and trimethoprim sulfate solution/ drops 10000 [iU]/mL (ANDA)
|
REMEDYREPACK INC. |
polymyxin b sulfate and trimethoprim sulfate |
D11086
|
|
Topiramate tablet 25 mg (ANDA)
|
REMEDYREPACK INC. |
Topiramate |
D00537
|
|
Mometasone Furoate cream 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Mometasone Furoate |
D00690
|
|
Clobetasol Propionate lotion .5 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
clobetasol propionate |
D01272
|
|
Naftifine Hydrochloride cream 10 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Naftifine Hydrochloride |
D00883
|
|
Mometasone Furoate ointment 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Mometasone Furoate |
D00690
|
|
Omeprazole capsule, delayed release 40 mg (ANDA)
|
REMEDYREPACK INC. |
Omeprazole |
D00455
|
|
Betamethasone dipropionate spray .5 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Betamethasone dipropionate |
D01637
|
|
FLULAVAL 2025/2026 suspension 15 ug/.5mL (BLA)
|
ID Biomedical Corporation of Quebec |
influenza virus vaccine |
D04536
|
|
Bumetanide tablet 1 mg (ANDA)
|
REMEDYREPACK INC. |
Bumetanide |
D00247
|
|
FLUZONE HIGH DOSE NORTHERN HEMISPHERE 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/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
D04536
|
|
Clotrimazole and Betamethasone Dipropionate lotion .5 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clotrimazole and Betamethasone Dipropionate |
D10300
|
|
DOXYCYCLINE HYCLATE tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
DOXYCYCLINE HYCLATE |
D02129
|
|
Acyclovir tablet 400 mg (ANDA)
|
Bryant Ranch Prepack |
Acyclovir |
D00222
|
|
IPRATROPIUM BROMIDE spray, metered 42 ug (ANDA)
|
Lupin Pharmaceuticals, Inc. |
IPRATROPIUM BROMIDE |
D02212
|
|
Levetiracetam injection, solution, concentrate 500 mg/5mL (ANDA)
|
Sagent Pharmaceuticals |
Levetiracetam |
D00709
|
Fluconazole tablet 100 mg (ANDA)
Fluconazole tablet 200 mg (ANDA)
|
Cardinal Health 107, LLC |
Fluconazole |
D00322
|
|
Mycophenolate mofetil tablet, film coated 500 mg (ANDA)
|
Cardinal Health 107, LLC |
Mycophenolate mofetil |
D00752
|
|
HYDROXYZINE HYDROCHLORIDE tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
hydroxyzine hydrochloride |
D00672
|
|
Rhofade cream 10 mg/g (NDA)
|
Mayne Pharma |
oxymetazoline hydrochloride |
D01022
|
|
Furosemide injection, solution 10 mg/mL (ANDA)
|
NorthStar Rx LLC |
Furosemide |
D00331
|
|
OXYGEN gas 992 mL/L (NDA)
|
Welders Supply Company |
OXYGEN |
D00003
|
|
Bumetanide tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
Bumetanide |
D00247
|
|
Amlodipine Besylate and Benazepril Hydrochloride capsule 5 mg (ANDA)
|
REMEDYREPACK INC. |
Amlodipine Besylate and Benazepril Hydrochloride |
D11069
|
|
Tizanidine tablet 4 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Tizanidine |
D00776
|
Guanfacine tablet, extended release 1 mg (ANDA)
Guanfacine tablet, extended release 2 mg (ANDA)
Guanfacine tablet, extended release 3 mg (ANDA)
Guanfacine tablet, extended release 4 mg (ANDA)
|
Fosun Pharma USA, Inc |
guanfacine |
D00606
|
Solu-Medrol injection, powder, for solution 125 mg/2mL (NDA)
Solu-Medrol injection, powder, for solution 40 mg/mL (NDA)
|
Cardinal Health 107, LLC |
methylprednisolone sodium succinate |
D00751
|
|
Fosaprepitant injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
BluePoint Laboratories |
Fosaprepitant dimeglumine |
D06597
|
|
Divalproex Sodium tablet, extended release 250 mg (ANDA)
|
Dr. Reddy's Laboratories Ltd |
Divalproex Sodium |
D00304
|
|
Chlorzoxazone tablet 500 mg (ANDA)
|
Actavis Pharma, Inc. |
Chlorzoxazone |
D00771
|
|
Doxycycline Hyclate tablet, coated 100 mg (ANDA)
|
Oncora Pharma, LLC |
Doxycycline hyclate |
D02129
|
|
Flucelvax injection, suspension 15 ug/.5mL (BLA)
|
Seqirus Inc. |
INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Victoria/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED),INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
D04536
|
|
Vyondys 53 injection 50 mg/mL (NDA)
|
Sarepta Therapeutics, Inc. |
golodirsen |
D11707
|
Prazosin Hydrochloride capsule 1 mg (ANDA)
Prazosin Hydrochloride capsule 2 mg (ANDA)
Prazosin Hydrochloride capsule 5 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Prazosin Hydrochloride |
D00609
|
|
METFORMIN HYDROCHLORIDE tablet 850 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
METFORMIN HYDROCHLORIDE |
D00944
|
|
NALTREXONE HYDROCHLORIDE tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
naltrexone hydrochloride |
D02095
|
|
Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metformin Hydrochloride |
D00944
|
|
Ketoconazole cream 20 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Ketoconazole |
D00351
|
brexpiprazole tablet, film coated .25 mg (ANDA)
brexpiprazole tablet, film coated .5 mg (ANDA)
brexpiprazole tablet, film coated 1 mg (ANDA)
brexpiprazole tablet, film coated 2 mg (ANDA)
brexpiprazole tablet, film coated 3 mg (ANDA)
brexpiprazole tablet, film coated 4 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
brexpiprazole |
D10309
|