| Product |
Company |
Generic name |
KEGG DRUG |
|
Tembexa tablet, film coated 100 mg (NDA)
|
Emergent BioDefense Operations Lansing LLC |
Brincidofovir |
D10547
|
Topamax tablet, coated 25 mg (NDA)
Topamax tablet, coated 50 mg (NDA)
Topamax tablet, coated 100 mg (NDA)
Topamax tablet, coated 200 mg (NDA)
Topamax capsule, coated pellets 25 mg (NDA)
Topamax capsule, coated pellets 15 mg (NDA)
|
Janssen Pharmaceuticals, Inc. |
topiramate |
D00537
|
|
Sotalol tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
Sotalol Hydrochloride |
D01026
|
|
OLMESARTAN MEDOXOMIL tablet 40 mg (ANDA)
|
Bryant Ranch Prepack |
olmesartan medoxomil |
D01204
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Irbesartan |
D00523
|
|
VORICONAZOLE injection, solution 10 mg/mL (ANDA)
|
Hainan Poly Pharm. Co., Ltd. |
VORICONAZOLE |
D00578
|
|
Gabapentin capsule 300 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
meloxicam tablet 7.5 mg (ANDA)
|
REMEDYREPACK INC. |
meloxicam |
D00969
|
|
Warfarin Sodium tablet 6 mg (ANDA)
|
REMEDYREPACK INC. |
Warfarin Sodium |
D00564
|
|
Chlordiazepoxide Hydrochloride capsule 25 mg (ANDA)
|
REMEDYREPACK INC. |
Chlordiazepoxide Hydrochloride |
D00693
|
|
Clonazepam tablet 1 mg (ANDA)
|
Proficient Rx LP |
Clonazepam |
D00280
|
|
Metformin HCL tablet, film coated 500 mg (ANDA)
|
Direct_Rx |
Metformin HCL |
D00944
|
|
Prolia injection 60 mg/mL (BLA)
|
Amgen, Inc |
denosumab |
D03684
|
|
Diclofenac Sodium Delayed Release tablet, delayed release 75 mg (ANDA)
|
Redpharm Drug |
Diclofenac Sodium |
D00904
|
|
METOPROLOL TARTRATE tablet 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
METOPROLOL TARTRATE |
D00601
|
|
METOPROLOL TARTRATE tablet 25 mg (ANDA)
|
Redpharm Drug |
METOPROLOL TARTRATE |
D00601
|
|
Baclofen tablet 10 mg (ANDA)
|
Redpharm Drug |
Baclofen |
D00241
|
|
Phentermine HCL C-IV tablet 37.5 mg (ANDA)
|
Direct_Rx |
Phentermine HCL C-IV |
D05459
|
|
Sotalol tablet 120 mg (ANDA)
|
Bryant Ranch Prepack |
Sotalol Hydrochloride |
D01026
|
|
Quetiapine Fumarate tablet, film coated 400 mg (ANDA)
|
A-S Medication Solutions |
Quetiapine Fumarate |
D00458
|
|
Tizanidine tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
Tizanidine |
D00776
|
|
Sotalol tablet 160 mg (ANDA)
|
Bryant Ranch Prepack |
Sotalol Hydrochloride |
D01026
|
|
FOSAPREPITANT DIMEGLUMINE injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Qilu Pharmaceutical Co., Ltd. |
FOSAPREPITANT DIMEGLUMINE |
D06597
|
|
Rectiv ointment 4 mg/g (NDA)
|
Allergan, Inc. |
nitroglycerin |
D00515
|
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
|
Bryant Ranch Prepack |
Penicillin V Potassium |
D00497
|
|
LEVETIRACETAM solution solution 100 mg/mL (ANDA)
|
Chartwell RX, LLC |
LEVETIRACETAM |
D00709
|
Calcitriol capsule, liquid filled .25 ug (ANDA)
Calcitriol capsule, liquid filled .5 ug (ANDA)
|
BIONPHARMA INC. |
Calcitriol |
D00129
|
|
ATMEKSI suspension 750 mg/5mL (NDA)
|
Rosemont Pharmaceuticals LLC |
methocarbamol |
D00402
|
|
ZEPZELCA injection, powder, lyophilized, for solution .5 mg/mL (NDA)
|
Jazz Pharmaceuticals, Inc. |
Lurbinectedin |
D11644
|
SIVEXTRO tablet, film coated 200 mg (NDA)
SIVEXTRO injection, powder, lyophilized, for solution 200 mg/4mL (NDA)
|
Merck Sharp & Dohme LLC |
tedizolid phosphate |
D09686
|
PROMETHAZINE HYDROCHLORIDE tablet 12.5 mg (ANDA)
PROMETHAZINE HYDROCHLORIDE tablet 25 mg (ANDA)
PROMETHAZINE HYDROCHLORIDE tablet 50 mg (ANDA)
|
KVK-Tech, Inc. |
promethazine hydrochloride |
D00480
|
|
TOPIRAMATE solution 25 mg/mL (ANDA)
|
Ascend Laboratories, LLC |
TOPIRAMATE |
D00537
|
|
JAIMIESS kit (ANDA)
|
Xiromed, LLC. |
levonorgestrel / ethinyl estradiol and ethinyl estradiol |
D04482
|
Diltiazem Hydrochloride capsule, extended release 120 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 180 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 240 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 300 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 360 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Diltiazem Hydrochloride |
D00616
|
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)
|
Mylan Pharmaceuticals Inc. |
paroxetine hydrochloride hemihydrate |
D02260
|
INLYTA tablet, film coated 5 mg (NDA)
INLYTA tablet, film coated 1 mg (NDA)
|
U.S. Pharmaceuticals |
axitinib |
D03218
|
Clindamycin Hydrochloride capsule 75 mg (ANDA)
Clindamycin Hydrochloride capsule 150 mg (ANDA)
Clindamycin Hydrochloride capsule 300 mg (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
Clindamycin Hydrochloride |
D02132
|
|
Propranolol Hydrochloride tablet 20 mg (ANDA)
|
Bryant Ranch Prepack |
Propranolol Hydrochloride |
D00483
|
|
REZZAYO injection, powder, lyophilized, for solution 200 mg (NDA)
|
Melinta Therapeutics, LLC |
rezafungin |
D11198
|
|
Spironolactone and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
Spironolactone and Hydrochlorothiazide |
D10270
|