| Product |
Company |
Generic name |
KEGG DRUG |
|
Naproxen suspension 125 mg/5mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Naproxen |
D00118
|
DESMOPRESSIN ACETATE injection 40 ug0mL (ANDA)
DESMOPRESSIN ACETATE injection 4 ug/mL (ANDA)
|
UBI Pharma Inc. |
DESMOPRESSIN ACETATE |
D02235
|
|
Anastrozole tablet, coated 1 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Anastrozole |
D00960
|
|
Sotalol Hydrochloride tablet 80 mg (ANDA)
|
Proficient Rx LP |
Sotalol Hydrochloride |
D01026
|
|
Dimenhydrinate injection, solution 50 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Dimenhydrinate |
D00520
|
|
Cefdinir capsule 300 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Cefdinir |
D00917
|
|
Famotidine powder, for suspension 40 mg/5mL (ANDA)
|
Golden State Medical Supply, Inc. |
Famotidine |
D00318
|
|
Paroxetine tablet, film coated 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
paroxetine hydrochloride hemihydrate |
D02260
|
Ritalin tablet 5 mg (NDA)
Ritalin tablet 10 mg (NDA)
Ritalin tablet 20 mg (NDA)
|
Sandoz Inc |
methylphenidate hydrochloride |
D01296
|
|
Diclofenac Sodium tablet, film coated, extended release 100 mg (ANDA)
|
Proficient Rx LP |
Diclofenac Sodium |
D00904
|
|
Aripiprazole solution 1 mg/mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
Aripiprazole oral |
D01164
|
Tizanidine Hydrochloride capsule 2 mg (ANDA)
Tizanidine Hydrochloride capsule 4 mg (ANDA)
Tizanidine Hydrochloride capsule 6 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Tizanidine Hydrochloride |
D00776
|
Tizanidine tablet 4 mg (ANDA)
Tizanidine tablet 2 mg (ANDA)
|
Bryant Ranch Prepack |
Tizanidine |
D00776
|
Cefpodoxime Proxetil tablet, film coated 100 mg (ANDA)
Cefpodoxime Proxetil tablet, film coated 200 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Cefpodoxime Proxetil |
D00920
|
Procainamide Hydrochloride injection, solution 100 mg/mL (ANDA)
Procainamide Hydrochloride injection, solution 500 mg/mL (ANDA)
|
Caplin Steriles Limited |
Procainamide Hydrochloride |
D00477
|
Prednisone tablet 5 mg (ANDA)
Prednisone tablet 10 mg (ANDA)
Prednisone tablet 20 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
Prednisone |
D00473
|
|
Chlorthalidone tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
Chlorthalidone |
D00272
|
Ibuprofen tablet 400 mg (ANDA)
Ibuprofen tablet 600 mg (ANDA)
Ibuprofen tablet 800 mg (ANDA)
|
Aurobindo Pharma Limited |
Ibuprofen |
D00126
|
|
Vivotif capsule, coated 6000000000 [CFU] (BLA)
|
Bavarian Nordic A/S |
Salmonella typhi Ty21a |
D06261
|
|
hydrocortisone lotion 25 mg/mL (ANDA)
|
Bryant Ranch Prepack |
hydrocortisone |
D00088
|
INVEGA SUSTENNA injection 39 mg/.25mL (NDA)
INVEGA SUSTENNA injection 78 mg/.5mL (NDA)
INVEGA SUSTENNA injection 117 mg/.75mL (NDA)
INVEGA SUSTENNA injection 156 mg/mL (NDA)
INVEGA SUSTENNA injection 234 mg.5mL (NDA)
|
Janssen Pharmaceuticals, Inc. |
paliperidone palmitate |
D05340
|
|
topiramate tablet, film coated 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
topiramate |
D00537
|
|
Ciclopirox Olamine suspension 7.7 mg00mL (ANDA)
|
Bryant Ranch Prepack |
Ciclopirox Olamine |
D01364
|
|
Vaxchora kit (BLA)
|
Bavarian Nordic A/S |
Cholera Vaccine, Live, Oral |
D03530
|
|
Meclizine Hydrochloride tablet 25 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Meclizine Hydrochloride |
D01317
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Lidocaine |
D00358
|
|
DURYSTA implant 10 ug (NDA)
|
Allergan, Inc. |
bimatoprost |
D02724
|
Hydrochlorothiazide tablet 25 mg (ANDA)
Hydrochlorothiazide tablet 50 mg (ANDA)
|
Proficient Rx LP |
Hydrochlorothiazide |
D00340
|
|
Zidovudine syrup 10 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
Zidovudine |
D00413
|
|
CHLORPROMAZINE HYDROCHLORIDE injection 25 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
CHLORPROMAZINE HYDROCHLORIDE |
D00789
|
|
DEXAMETHASONE SODIUM PHOSPHATE injection, solution 10 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
DEXAMETHASONE SODIUM PHOSPHATE |
D00975
|
AMLODIPINE BESYLATE 2.5 mg tablet 2.5 mg (ANDA)
AMLODIPINE BESYLATE 5 mg tablet 5 mg (ANDA)
AMLODIPINE BESYLATE 10 mg tablet 10 mg (ANDA)
|
Proficient Rx LP |
AMLODIPINE BESYLATE |
D00615
|
|
Labetalol Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Caplin Steriles Limited |
Labetalol Hydrochloride |
D00600
|
Carvedilol tablet, film coated 6.25 mg (ANDA)
Carvedilol tablet, film coated 25 mg (ANDA)
|
Preferred Pharmaceuticals,Inc. |
Carvedilol |
D00255
|
|
RabAvert kit (BLA)
|
Bavarian Nordic A/S |
Rabies Vaccine |
D06504
|
|
CARVEDILOL tablet, film coated 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
CARVEDILOL |
D00255
|
|
Paroxetine tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
paroxetine hydrochloride hemihydrate |
D02260
|
|
Zidovudine capsule 100 mg (ANDA)
|
Aurobindo Pharma Limited |
Zidovudine |
D00413
|
Spironolactone tablet, coated 25 mg (ANDA)
Spironolactone tablet, coated 50 mg (ANDA)
Spironolactone tablet, coated 100 mg (ANDA)
|
Proficient Rx LP |
Spironolactone |
D00443
|
|
Osphena tablet, film coated 60 mg (NDA)
|
Duchesnay USA, Inc. |
Ospemifene |
D08958
|