| Product |
Company |
Generic name |
KEGG DRUG |
|
Ipratropium Bromide and Albuterol Sulfate solution 3 mg/3mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Advanced Rx of Tennessee, LLC |
Lidocaine |
D00358
|
|
voriconazole powder, for suspension 40 mg/mL (ANDA)
|
Zhejiang Poly Pharm Co., Ltd. |
voriconazole |
D00578
|
|
MEMANTINE solution 2 mg/mL (ANDA)
|
Apotex Corp. |
memantine hydrochloride |
D04905
|
|
Tasimelteon capsule 20 mg (ANDA)
|
Apotex Corp. |
Tasimelteon |
D09388
|
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)
|
NORTHSTAR RX LLC |
ATORVASTATIN CALCIUM |
D11095
|
|
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
|
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
|
|
Ipratropium Bromide and Albuterol Sulfate solution 3 mg/3mL (ANDA)
|
Nephron Pharmaceuticals Corporation |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
Felodipine tablet, film coated 5 mg (ANDA)
Felodipine tablet, film coated 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Felodipine |
D00319
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
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
|
|
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
|
|
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
|
Nabumetone tablet, film coated 500 mg (ANDA)
Nabumetone tablet, film coated 750 mg (ANDA)
|
Exelan Pharmaceuticals Inc. |
Nabumetone |
D00425
|
|
Lorazepam tablet 1 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lorazepam |
D00365
|
Cefazolin Sodium solution 1 g/50mL (NDA)
Cefazolin Sodium solution 2 g/50mL (NDA)
Cefazolin Sodium solution 3 g/50mL (NDA)
|
B. Braun Medical Inc. |
Cefazolin Sodium |
D00905
|
|
PROCHLORPERAZINE MALEATE tablet, film coated 5 mg (ANDA)
|
Redpharm Drug |
Prochlorperazine Maleate |
D00479
|
Sulfamethoxazole and Trimethoprim tablet 400 mg (ANDA)
Sulfamethoxazole and Trimethoprim tablet 800 mg (ANDA)
|
Cronus Pharma LLC |
Sulfamethoxazole and Trimethoprim |
D00285
|
|
Diclofenac Sodium tablet, delayed release 75 mg (ANDA)
|
RedPharm Drug |
Diclofenac Sodium |
D00904
|