| Product |
Company |
Generic name |
KEGG DRUG |
|
Flucelvax injection, suspension 15 ug/.5mL (BLA)
|
Bamboo US BidCo LLC |
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) |
|
|
TOBRAMYCIN solution 300 mg/5mL (ANDA)
|
Lifestar Pharma LLC |
Tobramycin |
D00063
|
|
Cefuroxime Axetil tablet, film coated 250 mg (ANDA)
|
Redpharm Drug |
Cefuroxime Axetil |
D00914
|
PRIALT injection, solution 100 ug/mL (NDA)
PRIALT injection, solution 500 ug/5mL (NDA)
PRIALT injection, solution 500 ug/20mL (NDA)
|
ESTEVE PHARMACEUTICALS, S.A. |
ziconotide acetate |
D08686
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Redpharm Drug |
Amoxicillin |
D00229
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
Redpharm Drug |
Ciprofloxacin Hydrochloride |
D02216
|
|
Valacyclovir Hydrochloride tablet, film coated 1 g (ANDA)
|
Redpharm Drug |
Valacyclovir Hydrochloride |
D00398
|
|
Dicyclomine Hydrochloride tablet 20 mg (ANDA)
|
Redpharm Drug |
Dicyclomine Hydrochloride |
D00717
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Naltrexone Hydrochloride |
D02095
|
|
MORPHINE SULFATE tablet 15 mg (ANDA)
|
St. Mary's Medical Park Pharmacy |
MORPHINE SULFATE |
D00842
|
doxepin hydrochloride tablet 3 mg (ANDA)
doxepin hydrochloride tablet 6 mg (ANDA)
|
Golden State Medical Supply, Inc. |
doxepin hydrochloride |
D00814
|
LAMOTRIGINE tablet 25 mg (ANDA)
LAMOTRIGINE tablet 50 mg (ANDA)
LAMOTRIGINE tablet 100 mg (ANDA)
LAMOTRIGINE tablet 200 mg (ANDA)
|
Golden State Medical Supply, Inc. |
lamotrigine |
D00354
|
|
Midazolam Hydrochloride injection, solution 5 mg/mL (ANDA)
|
A-S Medication Solutions |
MIDAZOLAM HYDROCHLORIDE |
D00696
|
|
Topiramate tablet, film coated 100 mg (ANDA)
|
REMEDYREPACK INC. |
Topiramate |
D00537
|
CLOZAPINE tablet 25 mg (ANDA)
CLOZAPINE tablet 50 mg (ANDA)
CLOZAPINE tablet 100 mg (ANDA)
CLOZAPINE tablet 200 mg (ANDA)
|
NorthStar Rx LLC |
CLOZAPINE |
D00283
|
|
Argatroban injection, solution 1 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
Argatroban |
D00181
|
Minivelle film, extended release .1 mg/d (NDA)
Minivelle film, extended release .0375 mg/d (NDA)
Minivelle film, extended release .05 mg/d (NDA)
Minivelle film, extended release .075 mg/d (NDA)
Minivelle film, extended release .025 mg/d (NDA)
|
Noven Therapeutics, LLC |
estradiol |
D00105
|
|
meloxicam tablet 7.5 mg (ANDA)
|
REMEDYREPACK INC. |
meloxicam |
D00969
|
DOXEPIN tablet 3 mg (ANDA)
DOXEPIN tablet 6 mg (ANDA)
|
NorthStar Rx LLC |
DOXEPIN |
D00814
|
|
TOBRAMYCIN solution 300 mg/5mL (ANDA)
|
NorthStar RxLLC |
Tobramycin |
D00063
|
|
Finasteride tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Finasteride |
D00321
|
|
AMPICILLIN injection, powder, for solution 1 g (ANDA)
|
Henry Schein, Inc. |
Ampicillin Sodium |
D02119
|
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
Trazodone Hydrochloride |
D00820
|
Aripiprazole tablet 2 mg (ANDA)
Aripiprazole tablet 5 mg (ANDA)
Aripiprazole tablet 10 mg (ANDA)
Aripiprazole tablet 15 mg (ANDA)
Aripiprazole tablet 20 mg (ANDA)
Aripiprazole tablet 30 mg (ANDA)
|
Aurobindo Pharma Limited |
Aripiprazole |
D01164
|
|
Potassium Chloride Extended-Release tablet, extended release 750 mg (ANDA)
|
REMEDYREPACK INC. |
Potassium Chloride |
D02060
|
|
Clindamycin hydrochloride capsule 150 mg (ANDA)
|
REMEDYREPACK INC. |
Clindamycin hydrochloride |
D02132
|
|
CABERGOLINE tablet .5 mg (ANDA)
|
Cranbury Pharmaceuticals, LLC |
CABERGOLINE |
D00987
|
|
Ammonium Lactate lotion 120 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Ammonium Lactate |
D02920
|
|
REZZAYO injection, powder, lyophilized, for solution 200 mg (NDA)
|
Melinta Therapeutics, LLC |
rezafungin |
D11198
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Omeprazole |
D00455
|
|
Anectine injection, solution 20 mg/mL (NDA)
|
Sandoz Inc |
Succinylcholine Chloride |
D00766
|
|
Bupropion Hydrochloride XL tablet, film coated, extended release 150 mg (ANDA)
|
Actavis Pharma, Inc. |
Bupropion Hydrochloride |
D00817
|
nisoldipine tablet, film coated, extended release 8.5 mg (ANDA)
nisoldipine tablet, film coated, extended release 17 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
nisoldipine |
D00618
|
PRUCALOPRIDE tablet, film coated 1 mg (ANDA)
PRUCALOPRIDE tablet, film coated 2 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
PRUCALOPRIDE |
D10152
|
|
OTARMENI injection, solution 30000000000000 {GC}/mL (BLA)
|
Regeneron Pharmaceuticals, Inc. |
lunsotogene parvec-cwha |
D13347
|
|
Daysee kit (ANDA)
|
Lupin Pharmaceuticals, Inc. |
LEVONORGESTREL AND ETHINYL ESTRADIOL |
D04482
|
|
Typhim Vi injection, solution 25 ug/.5mL (BLA)
|
Sanofi Vaccines US Inc. |
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN |
D12923
|
Pravastatin sodium tablet 10 mg (ANDA)
Pravastatin sodium tablet 20 mg (ANDA)
Pravastatin sodium tablet 40 mg (ANDA)
Pravastatin sodium tablet 80 mg (ANDA)
|
Aurobindo Pharma Limited |
Pravastatin sodium |
D00893
|
Xtandi capsule 40 mg (NDA)
Xtandi tablet 40 mg (NDA)
Xtandi tablet 80 mg (NDA)
|
Astellas Pharma US, Inc. |
enzalutamide |
D10218
|
|
Ciprofloxacin Hydrochloride tablet, film coated 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc |
Ciprofloxacin Hydrochloride |
D02216
|