| Product |
Company |
Generic name |
KEGG DRUG |
|
ARMLUPEG injection 6 mg/.6mL (BLA)
|
Lupin Pharmaceuticals, Inc. |
pegfilgrastim-unne |
D06889
|
|
Pregabalin capsule 100 mg (ANDA)
|
Bryant Ranch Prepack |
PREGABALIN |
D02716
|
|
Fluorouracil injection, solution 50 mg/mL (ANDA)
|
BluePoint Laboratories |
Fluorouracil |
D00584
|
|
Desonide cream .5 mg/g (ANDA)
|
Bryant Ranch Prepack |
Desonide |
D03696
|
|
CARBAMAZEPINE tablet, chewable 100 mg (ANDA)
|
Bryant Ranch Prepack |
CARBAMAZEPINE |
D00252
|
|
levocetirizine dihydrochloride tablet 5 mg (ANDA)
|
Bryant Ranch Prepack |
levocetirizine dihydrochloride |
D08118
|
|
Cyclophosphamide injection 200 mg/mL (ANDA)
|
Nexus Pharmaceuticals, LLC |
Cyclophosphamide |
D00287
|
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g (ANDA)
|
Hospira, Inc. |
VANCOMYCIN HYDROCHLORIDE |
D00926
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
Metolazone tablet 10 mg (ANDA)
|
Amici Pharma, Inc |
Metolazone |
D00431
|
ZEGERID powder, for suspension 20 mg (NDA)
ZEGERID powder, for suspension 40 mg (NDA)
ZEGERID capsule 20 mg (NDA)
ZEGERID capsule 40 mg (NDA)
|
Santarus, Inc.. |
omeprazole and sodium bicarbonate |
D11706
|
|
Prednisone tablet 20 mg (ANDA)
|
Cardinal Health 107, LLC |
Prednisone |
D00473
|
|
Fluorouracil injection, solution 50 mg/mL (ANDA)
|
BluePoint Laboratories |
Fluorouracil |
D00584
|
|
Clarithromycin tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
Clarithromycin |
D00276
|
TOPIRAMATE capsule 15 mg (ANDA)
TOPIRAMATE capsule 25 mg (ANDA)
|
Aurobindo Pharma Limited |
TOPIRAMATE |
D00537
|
|
SUFLAVE kit (NDA)
|
Azurity Pharmaceuticals, Inc. |
polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution |
|
|
metronidazole tablet 500 mg (ANDA)
|
REMEDYREPACK INC. |
metronidazole |
D00409
|
|
Levorphanol Tartrate tablet 2 mg (ANDA)
|
Bryant Ranch Prepack |
Levorphanol Tartrate |
D00841
|
|
Morphine Sulfate solution 20 mg/mL (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Morphine Sulfate |
D00842
|
|
Pregabalin capsule 150 mg (ANDA)
|
Bryant Ranch Prepack |
PREGABALIN |
D02716
|
Allopurinol tablet 100 mg (ANDA)
Allopurinol tablet 300 mg (ANDA)
|
Safecor Health, LLC |
allopurinol |
D00224
|
|
Pregabalin capsule 200 mg (ANDA)
|
Bryant Ranch Prepack |
PREGABALIN |
D02716
|
|
Oxycodone Hydrochloride solution 5 mg/5mL (ANDA)
|
Bryant Ranch Prepack |
Oxycodone Hydrochloride |
D00847
|
voriconazole tablet, film coated 50 mg (ANDA)
voriconazole tablet, film coated 200 mg (ANDA)
|
Sandoz Inc |
voriconazole |
D00578
|
Topiramate capsule, extended release 25 mg (ANDA)
Topiramate capsule, extended release 50 mg (ANDA)
Topiramate capsule, extended release 100 mg (ANDA)
Topiramate capsule, extended release 200 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Topiramate |
D00537
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
cyclobenzaprine hydrochloride |
D00772
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
cyclobenzaprine hydrochloride |
D00772
|
|
Clopidogrel bisulfate tablet, film coated 75 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Clopidogrel bisulfate |
D00769
|
ROPINIROLE tablet, film coated .25 mg (ANDA)
ROPINIROLE tablet, film coated 1 mg (ANDA)
|
Major Pharmaceuticals |
ROPINIROLE |
D00784
|
|
Gabapentin capsule 300 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
Colchicine capsule .6 mg (ANDA)
|
Par Health USA, LLC |
Colchicine |
D00570
|
|
Colchicine capsule .6 mg (NDA)
|
Hikma Pharmaceuticals USA Inc. |
Colchicine |
D00570
|
|
Divalproex Sodium tablet, extended release 500 mg (ANDA)
|
Major Pharmaceuticals |
Divalproex Sodium |
D00304
|
Methadone Hydrochloride tablet 5 mg (ANDA)
Methadone Hydrochloride tablet 10 mg (ANDA)
|
Ascend Laboratories, LLC |
Methadone Hydrochloride |
D02102
|
|
ILEVRO suspension/ drops 3 mg/mL (NDA)
|
Novartis Pharmaceuticals Corporation |
nepafenac |
D05143
|
CARDENE IV injection, solution .2 mg/mL (NDA)
CARDENE IV injection, solution .1 mg/mL (NDA)
|
Baxter Healthcare Corporation |
nicardipine hydrochloride |
D00617
|
|
Clonazepam tablet 1 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Clonazepam |
D00280
|
VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated 12.5 mg (ANDA)
VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated 25 mg (ANDA)
|
Solco Healthcare US, LLC |
valsartan and hydrochlorothiazide |
D09197
|
|
Methadone Hydrocloride dye-free, sugar-free, unflavored concentrate 10 mg/mL (ANDA)
|
Bryant Ranch Prepack |
methadone hydrochloride |
D02102
|
|
Sodium Chloride injection 900 mg00mL (NDA)
|
Baxter Healthcare Corporation |
Sodium Chloride |
D02056
|
|
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
|
Bryant Ranch Prepack |
bupropion hydrochloride |
D00817
|