| Product |
Company |
Generic name |
KEGG DRUG |
|
PYLERA capsule 140 mg (NDA)
|
H2-Pharma, LLC |
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE |
D10245
|
|
Nelarabine injection 5 mg/mL (ANDA)
|
Gland Pharma Limited |
Nelarabine |
D05134
|
|
Tymlos injection, solution 3.12 mg.56mL (NDA)
|
Radius Health, Inc. |
abaloparatide |
D10885
|
VARENICLINE tablet, film coated .5 mg (ANDA)
VARENICLINE tablet, film coated 1 mg (ANDA)
VARENICLINE kit (ANDA)
|
Apotex Corp |
VARENICLINE |
D06282
|
|
Calcitonin Salmon injection, solution 200 [USP'U]/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
calcitonin salmon |
D00249
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g/20mL (ANDA)
|
Medimetriks Pharmaceuticals, Inc. |
Vancomycin hydrochloride |
D00926
|
Calcitriol capsule, liquid filled .25 ug (ANDA)
Calcitriol capsule, liquid filled .5 ug (ANDA)
|
Golden State Medical Supply, Inc. |
Calcitriol |
D00129
|
Niacin tablet, extended release 500 mg (ANDA)
Niacin tablet, extended release 1000 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Niacin |
D00049
|
Olanzapine tablet, orally disintegrating 5 mg (ANDA)
Olanzapine tablet, orally disintegrating 10 mg (ANDA)
Olanzapine tablet, orally disintegrating 15 mg (ANDA)
Olanzapine tablet, orally disintegrating 20 mg (ANDA)
|
Apotex Corp. |
Olanzapine |
D00454
|
|
Amoxicillin and Clavulanate Potassium suspension 600 mg/5mL (ANDA)
|
Sandoz Inc |
Amoxicillin and Clavulanate Potassium |
D06485
|
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE tablet, film coated 5 mg (ANDA)
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE tablet, film coated 10 mg (ANDA)
|
Strides Pharma Science Limited |
amlodipine besylate valsartan hydrochlorothiazide |
D10286
|
|
Donepezil Hydrochloride tablet, film coated 23 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Donepezil Hydrochloride |
D00670
|
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 150 mg (ANDA)
Topiramate capsule, extended release 200 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Topiramate |
D00537
|
|
Esomeprazole Magnesium capsule, delayed release 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Esomeprazole Magnesium |
D01984
|
|
Ipratropium Bromide and Albuterol Sulfate solution 3 mg/3mL (ANDA)
|
Nephron Pharmaceuticals Corporation |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
Risedronate Sodium tablet, film coated 75 mg (ANDA)
Risedronate Sodium tablet, film coated 150 mg (ANDA)
Risedronate Sodium tablet, film coated 35 mg (ANDA)
|
Apotex Corp. |
Risedronate Sodium |
D03234
|
Felodipine tablet, film coated 5 mg (ANDA)
Felodipine tablet, film coated 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Felodipine |
D00319
|
ziprasidone hydrochloride capsule 20 mg (ANDA)
ziprasidone hydrochloride capsule 40 mg (ANDA)
ziprasidone hydrochloride capsule 60 mg (ANDA)
ziprasidone hydrochloride capsule 80 mg (ANDA)
|
Apotex Corp. |
Ziprasidone HCl |
D01939
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
Meloxicam tablet 7.5 mg (ANDA)
Meloxicam tablet 15 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Meloxicam |
D00969
|
|
clarithromycin tablet, film coated, extended release 500 mg (ANDA)
|
Actavis Pharma, Inc. |
clarithromycin |
D00276
|
ATORVASTATIN CALCIUM tablet, film coated 10 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 20 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 40 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
Apotex Corp. |
ATORVASTATIN CALCIUM |
D11095
|
|
POSACONAZOLE tablet, delayed release 100 mg (ANDA)
|
Golden State Medical Supply, Inc. |
posaconazole |
D02555
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
ketorolac tromethamine |
D00813
|
ATORVASTATIN CALCIUM tablet, film coated 10 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 20 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 40 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
Quallent |
ATORVASTATIN CALCIUM |
D11095
|
Budesonide inhalant .25 mg/2mL (ANDA)
Budesonide inhalant .5 mg/2mL (ANDA)
|
Nephron Pharmaceuticals Corporation |
BUDESONIDE |
D00246
|
|
Doxorubicin Hydrochloride injectable, liposomal 2 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Doxorubicin Hydrochloride |
D01275
|
|
Oxygen gas 992 mL/L (NDA)
|
Arkansas Welding Supply, Inc. |
Oxygen |
D00003
|
|
Norgestimate and Ethinyl Estradiol kit (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Norgestimate and Ethinyl Estradiol |
D10590
|
|
SODIUM POLYSTYRENE SULFONATE powder, for suspension 4.1 meq/g (ANDA)
|
Bryant Ranch Prepack |
sodium polystyrene sulfonate |
D03263
|
Naproxen tablet, delayed release 375 mg (ANDA)
Naproxen tablet, delayed release 500 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Naproxen |
D00118
|
|
Levofloxacin tablet, film coated 500 mg (ANDA)
|
Redpharm Drug |
Levofloxacin |
D00588
|
|
AMOXICILLIN capsule 500 mg (ANDA)
|
Redpharm Drug |
Amoxicillin |
D00229
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 10 mg (ANDA)
|
Redpharm Drug |
cyclobenzaprine hydrochloride |
D00772
|
PROCRIT injection, solution 2000 [iU]/mL (BLA)
PROCRIT injection, solution 3000 [iU]/mL (BLA)
PROCRIT injection, solution 4000 [iU]/mL (BLA)
PROCRIT injection, solution 10000 [iU]/mL (BLA)
PROCRIT injection, solution 40000 [iU]/mL (BLA)
PROCRIT injection, solution 20000 [iU]/mL (BLA)
|
Janssen Products, LP |
Erythropoietin |
D03231
|
|
Prochlorperazine Edisylate injection 5 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Prochlorperazine Edisylate |
D02609
|
VYKAT XR tablet, film coated 25 mg (NDA)
VYKAT XR tablet, film coated 75 mg (NDA)
VYKAT XR tablet, film coated 150 mg (NDA)
|
Soleno Therapeutics, Inc. |
diazoxide choline |
D12987
|
|
Donepezil Hydrochloride tablet, film coated 23 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Donepezil Hydrochloride |
D00670
|
|
Hydrocodone Bitartrate and Acetaminophen solution 325 mg5mL (ANDA)
|
Redpharm drug |
hydrocodone bitartrate and acetaminophen |
D00846
|
Nadolol tablet 20 mg (ANDA)
Nadolol tablet 40 mg (ANDA)
Nadolol tablet 80 mg (ANDA)
|
BluePoint Laboratories |
Nadolol |
D00432
|