| Product |
Company |
Generic name |
KEGG DRUG |
|
clindamycin palmitate hydrochloride granule, for solution 75 mg/5mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
clindamycin palmitate hydrochloride |
D01990
|
|
POTASSIUM CHLORIDE injection, solution, concentrate 14.9 g00mL (ANDA)
|
B. Braun Medical Inc. |
POTASSIUM CHLORIDE |
D02060
|
|
Posaconazole tablet, delayed release 100 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Posaconazole |
D02555
|
|
MEDROXYPROGESTERONE ACETATE injection, suspension 150 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
MEDROXYPROGESTERONE ACETATE |
D00951
|
|
Torsemide tablet 20 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Torsemide |
D00382
|
|
RIBAVIRIN powder, for solution 6 g (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
ribavirin |
D00423
|
|
RIBAVIRIN powder, for solution 6 g (ANDA)
|
Navinta LLC |
ribavirin |
D00423
|
Montelukast Sodium tablet, coated 10 mg (ANDA)
Montelukast Sodium tablet, chewable 4 mg (ANDA)
Montelukast Sodium tablet, chewable 5 mg (ANDA)
|
Dr.Reddy's Laboratories Limited |
Montelukast Sodium |
D00529
|
Paroxetine tablet, film coated, extended release 12.5 mg (ANDA)
Paroxetine tablet, film coated, extended release 25 mg (ANDA)
Paroxetine tablet, film coated, extended release 37.5 mg (ANDA)
|
Chartwell RX, LLC |
Paroxetine |
D02260
|
Neostigmine Methylsulfate injection, solution .5 mg/mL (NDA)
Neostigmine Methylsulfate injection, solution 1 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
Neostigmine Methylsulfate |
D00998
|
|
Allopurinol tablet 300 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Allopurinol |
D00224
|
|
Atovaquone and Proguanil Hydrochloride tablet, film coated 250 mg (ANDA)
|
BluePoint Laboratories |
Atovaquone and Proguanil Hydrochloride |
D02472
|
|
Fluocinonide cream 1 mg/g (ANDA)
|
Asclemed USA, Inc. |
Fluocinonide |
D00325
|
|
rocuronium bromide solution 10 mg/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
rocuronium bromide |
D00765
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
Asclemed USA, Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
Carbidopa and Levodopa tablet 10 mg (ANDA)
Carbidopa and Levodopa tablet 25 mg (ANDA)
|
Aurobindo Pharma Limited |
Carbidopa and Levodopa |
D00253
|
|
Chlorhexidine Gluconate rinse 1.2 mg/mL (ANDA)
|
Proficient Rx LP |
Chlorhexidine Gluconate |
D00858
|
Darifenacin tablet, extended release 7.5 mg (ANDA)
Darifenacin tablet, extended release 15 mg (ANDA)
|
POLYGEN PHARMACEUTICALS INC. |
Darifenacin Hydrobromide |
D01699
|
|
Sulfasalazine tablet 500 mg (ANDA)
|
Chartwell RX, LLC. |
Sulfasalazine |
D00448
|
|
Penicillamine capsule 250 mg (ANDA)
|
Navinta LLC |
Penicillamine |
D00496
|
|
BUDESONIDE (ENTERIC COATED) capsule, delayed release pellets 3 mg (ANDA)
|
Mayne Pharma Inc. |
Budesonide |
D00246
|
|
Calcipotriene cream 50 ug/g (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
Calcipotriene |
D10198
|
|
Clofarabine injection 1 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Clofarabine |
D03546
|
Methimazole tablet 5 mg (ANDA)
Methimazole tablet 10 mg (ANDA)
|
Chartwell RX, LLC |
Methimazole |
D00401
|
|
Nystatin powder 100000 [USP'U]/g (ANDA)
|
Mayne Pharma Inc. |
Nystatin |
D00202
|
|
TENOFOVIR DISOPROXIL FUMARATE tablet, film coated 300 mg (ANDA)
|
Chartwell RX, LLC. |
TENOFOVIR DISOPROXIL FUMARATE Tablets |
D01982
|
|
FAMOTIDINE powder, for suspension 40 mg/5mL (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
famotidine |
D00318
|
|
Calcipotriene and Betamethasone Dipropionate ointment .5 mg/g (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
Calcipotriene and Betamethasone Dipropionate |
D10534
|
Oseltamivir Phosphate capsule 30 mg (ANDA)
Oseltamivir Phosphate capsule 45 mg (ANDA)
Oseltamivir Phosphate capsule 75 mg (ANDA)
|
Strides Pharma Science Limited |
Oseltamivir Phosphate |
D00900
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
Cadila Pharmaceuticals Limited |
Labetalol Hydrochloride |
D00600
|
|
Nabumetone tablet, film coated 500 mg (ANDA)
|
Proficient Rx LP |
Nabumetone |
D00425
|
|
Ipratropium Bromide and Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Proficient Rx LP |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
Midazolam Hydrochloride syrup 2 mg/mL (ANDA)
|
Padagis US LLC |
Midazolam Hydrochloride |
D00696
|
|
Sertraline Hydrochloride tablet, film coated 100 mg (ANDA)
|
Proficient Rx LP |
Sertraline Hydrochloride |
D00825
|
|
Metronidazole tablet 250 mg (ANDA)
|
Proficient Rx LP |
Metronidazole |
D00409
|
|
Junel Fe 1.5/30 kit (ANDA)
|
Proficient Rx LP |
norethindrone acetate and ethinyl estradiol, and ferrous fumarate |
D04483
|
Lamotrigine tablet 25 mg (ANDA)
Lamotrigine tablet 100 mg (ANDA)
Lamotrigine tablet 150 mg (ANDA)
Lamotrigine tablet 200 mg (ANDA)
|
Ascend Laboratories, LLC |
Lamotrigine |
D00354
|
|
25% Dextrose Infant injection, solution 250 mg/mL (NDA)
|
HF Acquisition Co. LLC, DBA Health First |
25% Dextrose Infant |
D02325
|
|
NALOXONE HYDROCHLORIDE injection, solution .4 mg/mL (ANDA)
|
HF Acquisition Co. LLC, DBA HealthFirst |
NALOXONE HYDROCHLORIDE |
D01340
|
EPINEPHRINE injection .15 mg/.15mL (NDA AUTHORIZED GENERIC)
EPINEPHRINE injection .3 mg/.3mL (NDA AUTHORIZED GENERIC)
|
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE |
D00095
|