| Product |
Company |
Generic name |
KEGG DRUG |
|
Glycopyrrolate injection .2 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Glycopyrrolate |
D00540
|
|
Famotidine powder, for solution 40 mg/5mL (ANDA)
|
Akorn |
Famotidine |
D00318
|
Neostigmine methylsulfate injection .5 mg/mL (ANDA)
Neostigmine methylsulfate injection 1 mg/mL (ANDA)
|
BE Pharmaceuticals Inc. |
Neostigmine methylsulfate |
D00998
|
|
Levetiracetam injection, solution 100 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
LEVETIRACETAM |
D00709
|
Metformin Hydrochloride tablet, film coated, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated, extended release 1000 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Metformin Hydrochloride Extended-Release Tablets |
D00944
|
Lacosamide tablet 50 mg (ANDA)
Lacosamide tablet 100 mg (ANDA)
Lacosamide tablet 150 mg (ANDA)
Lacosamide tablet 200 mg (ANDA)
|
Indoco Remedies Limited |
Lacosamide |
D07299
|
|
Quinidine gluconate tablet, extended release 324 mg (ANDA)
|
Eywa Pharma Inc |
Quinidine gluonate |
D00642
|
|
Buspirone Hydrochloride tablet 15 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Buspirone Hydrochloride |
D00702
|
Cephalexin capsule 250 mg (ANDA)
Cephalexin capsule 500 mg (ANDA)
Cephalexin powder, for suspension 125 mg/5mL (ANDA)
Cephalexin powder, for suspension 250 mg/5mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Cephalexin |
D00906
|
|
Cyproheptadine Hydrochloride syrup 2 mg/5mL (ANDA)
|
Tris Pharma Inc |
Cyproheptadine Hydrochloride |
D02234
|
Amlodipine besylate tablet 2.5 mg (ANDA)
Amlodipine besylate tablet 5 mg (ANDA)
Amlodipine besylate tablet 10 mg (ANDA)
|
Exelan Pharmaceuticals, Inc. |
Amlodipine besylate |
D00615
|
|
Sodium Chloride injection 9 mg/mL (NDA)
|
B. Braun Medical Inc. |
Sodium Chloride |
D02056
|
Cefprozil tablet, film coated 250 mg (ANDA)
Cefprozil tablet, film coated 500 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Cefprozil |
D00261
|
|
Montelukast tablet 10 mg (ANDA)
|
BluePoint Laboratories |
Montelukast |
D00529
|
|
Naloxone Hydrochloride Injection, USP, Auto-Injector injection, solution 10 mg/.4mL (NDA)
|
Kaleo, Inc. |
Naloxone Hydrochloride |
D01340
|
Nateglinide tablet, coated 60 mg (ANDA)
Nateglinide tablet, coated 120 mg (ANDA)
|
Modavar Pharmaceuticals LLC |
Nateglinide |
D01111
|
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
|
Furosemide tablet 40 mg (ANDA)
Furosemide tablet 20 mg (ANDA)
Furosemide tablet 80 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
furosemide |
D00331
|
|
Lisinopril tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lisinopril |
D00362
|
|
Glycopyrrolate injection .2 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Glycopyrrolate |
D00540
|
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
|
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
|
|
Bupropion Hydrochloride (SR) tablet, film coated, extended release 150 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
bupropion hydrochloride |
D00817
|
|
Tropicamide solution/ drops 5 mg/mL (ANDA)
|
Sandoz Inc |
Tropicamide |
D00397
|
CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated 10 mg (ANDA)
CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated 25 mg (ANDA)
|
Epic Pharma LLC |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
D00693
|
|
Silver Sulfadiazine cream 10 g000g (NDA)
|
Asclemed USA, Inc. |
Silver Sulfadiazine |
D00433
|
|
zoledronic acid injection, solution .04 mg/mL (NDA)
|
Sagent Pharmaceuticals |
zoledronic acid |
D01968
|
|
Nabumetone tablet 500 mg (ANDA)
|
Asclemed USA, Inc. |
Nabumetone |
D00425
|
|
Erythromycin ointment 5 mg/g (ANDA)
|
Asclemed USA, Inc. |
Erythromycin |
D00140
|
|
Rocuronium injection, solution 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
ROCURONIUM BROMIDE |
D00765
|
|
Amoxicillin tablet, coated 875 mg (ANDA)
|
Asclemed USA, Inc. |
Amoxicillin |
D00229
|
|
Fluconazole tablet 150 mg (ANDA)
|
Asclemed USA, Inc. |
Fluconazole |
D00322
|
|
Gentamicin Sulfate solution 3 mg/mL (ANDA)
|
Asclemed USA, Inc. |
Gentamicin Sulfate |
D01063
|
|
Lisinopril tablet 40 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lisinopril |
D00362
|
|
Sodium Fluoride F 18 injection 200 mCi/mL (ANDA)
|
The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute |
Sodium Fluoride F 18 |
D05860
|
|
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
ATORVASTATIN CALCIUM |
D11095
|
Deferasirox granule 90 mg (ANDA)
Deferasirox granule 180 mg (ANDA)
Deferasirox granule 360 mg (ANDA)
|
Cipla USA Inc. |
Deferasirox |
D03669
|
|
Meloxicam tablet 7.5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Meloxicam |
D00969
|