| Product |
Company |
Generic name |
KEGG DRUG |
Leucovorin Calcium injection, powder, lyophilized, for solution 200 mg/20mL (ANDA)
Leucovorin Calcium injection, powder, lyophilized, for solution 500 mg/50mL (ANDA)
|
Fresenius Kabi USA, LLC
|
LEUCOVORIN CALCIUM
|
D01211
|
|
Levora kit (ANDA)
|
Mayne Pharma Inc.
|
levonorgestrel and ethinyl estradiol
|
D04482
|
CELECOXIB capsule 50 mg (ANDA)
CELECOXIB capsule 100 mg (ANDA)
CELECOXIB capsule 200 mg (ANDA)
CELECOXIB capsule 400 mg (ANDA)
|
Micro Labs Limited
|
Celecoxib
|
D00567
|
|
Propranolol Hydrochloride tablet 20 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs
|
Propranolol Hydrochloride
|
D00483
|
Tolvaptan tablet 15 mg (ANDA)
Tolvaptan tablet 30 mg (ANDA)
|
Par Pharmaceutical, Inc.
|
Tolvaptan
|
D01213
|
Furosemide tablet 40 mg (ANDA)
Furosemide tablet 20 mg (ANDA)
Furosemide tablet 80 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
furosemide
|
D00331
|
Rosuvastatin Calcium tablet, film coated 5 mg (ANDA)
Rosuvastatin Calcium tablet, film coated 10 mg (ANDA)
Rosuvastatin Calcium tablet, film coated 20 mg (ANDA)
Rosuvastatin Calcium tablet, film coated 40 mg (ANDA)
|
QUALLENT
|
Rosuvastatin Calcium
|
D01915
|
|
Etesevimab injection, solution 35 mg/mL (EMERGENCY USE AUTHORIZATION)
|
Eli Lilly and Company
|
Etesevimab
|
D11944
|
Baclofen tablet 10 mg (ANDA)
Baclofen tablet 20 mg (ANDA)
|
Major Pharmaceuticals
|
baclofen
|
D00241
|
|
Lisinopril tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Lisinopril
|
D00362
|
|
Bamlanivimab injection, solution 35 mg/mL (EMERGENCY USE AUTHORIZATION)
|
Eli Lilly and Company
|
Bamlanivimab
|
D11936
|
|
Glycopyrrolate injection .2 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc.
|
Glycopyrrolate
|
D00540
|
|
Hydrochlorothiazide capsule 12.5 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Hydrochlorothiazide
|
D00340
|
|
Lovastatin tablet 40 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Lovastatin
|
D00359
|
Metoprolol Tartrate tablet, film coated 25 mg (ANDA)
Metoprolol Tartrate tablet, film coated 100 mg (ANDA)
Metoprolol Tartrate tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
metoprolol tartrate
|
D00601
|
|
Oxazepam capsule 15 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Oxazepam
|
D00464
|
Celecoxib capsule 50 mg (ANDA)
Celecoxib capsule 100 mg (ANDA)
Celecoxib capsule 200 mg (ANDA)
Celecoxib capsule 400 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc.
|
Celecoxib
|
D00567
|
|
FLUOXETINE capsule 20 mg (ANDA)
|
DIRECT RX
|
FLUOXETINE
|
D00823
|
glycopyrrolate injection .2 mg/mL (ANDA)
glycopyrrolate injection .4 mg/2mL (ANDA)
glycopyrrolate injection 1 mg/5mL (ANDA)
glycopyrrolate injection 4 mg/20mL (ANDA)
|
BE Pharmaceuticals Inc.
|
glycopyrrolate
|
D00540
|
|
Ciprofloxacin tablet, film coated 250 mg (ANDA)
|
Asclemed USA, Inc.
|
Ciprofloxacin
|
D02216
|
|
Naproxen Oral Suspension suspension 125 mg/5mL (ANDA)
|
Novitium Pharma LLC
|
Naproxen oral
|
D00118
|
|
Bupropion Hydrochloride (SR) tablet, film coated, extended release 150 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
bupropion hydrochloride
|
D00817
|
|
Trivora kit (ANDA)
|
Mayne Pharma Inc.
|
Levonorgestrel and Ethinyl Estradiol
|
D04482
|
|
Tropicamide solution/ drops 5 mg/mL (ANDA)
|
Sandoz Inc
|
Tropicamide
|
D00397
|
ropinirole hydrochloride tablet, film coated .25 mg (ANDA)
ropinirole hydrochloride tablet, film coated .5 mg (ANDA)
ropinirole hydrochloride tablet, film coated 1 mg (ANDA)
ropinirole hydrochloride tablet, film coated 2 mg (ANDA)
ropinirole hydrochloride tablet, film coated 3 mg (ANDA)
ropinirole hydrochloride tablet, film coated 4 mg (ANDA)
ropinirole hydrochloride tablet, film coated 5 mg (ANDA)
|
SOLCO HEALTHCARE US, LLC
|
ropinirole hydrochloride
|
D00784
|
Metoprolol succinate tablet, extended release 100 mg (ANDA)
Metoprolol succinate tablet, extended release 200 mg (ANDA)
|
Dr. Reddy's Laboratories Limited
|
Metoprolol succinate
|
D00635
|
|
BUPROPION HYDROCHLORIDE (SR) tablet, extended release 150 mg (ANDA)
|
Dr. Reddy's Laboratories Inc
|
Bupropion Hydrochloride
|
D00817
|
|
Tetracaine Hydrochloride solution/ drops 5 mg/mL (NDA)
|
Oceanside Pharmaceuticals
|
Tetracaine Hydrochloride
|
D00741
|
CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated 10 mg (ANDA)
CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated 25 mg (ANDA)
|
Epic Pharma LLC
|
CHLORDIAZEPOXIDE HYDROCHLORIDE
|
D00693
|
|
Low-Ogestrel kit (ANDA)
|
Mayne Pharma Inc.
|
Norgestrel and Ethinyl Estradiol
|
D04463
|
|
SRONYX kit (ANDA)
|
Mayne Pharma Inc.
|
Levonorgestrel and Ethinyl Estradiol
|
D04482
|
|
Silver Sulfadiazine cream 10 g000g (NDA)
|
Asclemed USA, Inc.
|
Silver Sulfadiazine
|
D00433
|
|
MOXIFLOXACIN solution/ drops 5 mg/mL (ANDA)
|
Direct Rx
|
MOXIFLOXACIN
|
D00874
|
|
ONDANSETRON tablet, orally disintegrating 8 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
ONDANSETRON
|
D00456
|
|
zoledronic acid injection, solution .04 mg/mL (NDA)
|
Sagent Pharmaceuticals
|
zoledronic acid
|
D01968
|
Morphine Sulfate solution 10 mg/5mL (ANDA)
Morphine Sulfate solution 20 mg/5mL (ANDA)
Morphine Sulfate solution 100 mg/5mL (ANDA)
|
Winder Laboratories LLC
|
Morphine Sulfate
|
D00842
|
|
Nabumetone tablet 500 mg (ANDA)
|
Asclemed USA, Inc.
|
Nabumetone
|
D00425
|
|
Azithromycin tablet, film coated 250 mg (ANDA)
|
Asclemed USA, Inc.
|
Azithromycin
|
D02134
|
|
Lidocaine Hydrochloride solution 20 mg/mL (ANDA)
|
Asclemed USA, Inc.
|
Lidocaine Hydrochloride
|
D02086
|
MUSE suppository 250 ug (NDA)
MUSE suppository 500 ug (NDA)
MUSE suppository 1000 ug (NDA)
|
Meda Pharmaceuticals Inc.
|
Alprostadil
|
D00180
|