| Product |
Company |
Generic name |
KEGG DRUG |
|
Edetate Calcium Disodium injection 200 mg/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Edetate Calcium Disodium |
D03943
|
ESOMEPRAZOLE MAGNESIUM capsule, delayed release 20 mg (ANDA)
ESOMEPRAZOLE MAGNESIUM capsule, delayed release 40 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
ESOMEPRAZOLE MAGNESIUM |
D01984
|
|
Finasteride tablet 5 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Finasteride |
D00321
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
Metolazone tablet 10 mg (ANDA)
|
Micro Labs Limited |
Metolazone |
D00431
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
Celecoxib capsule 100 mg (ANDA)
Celecoxib capsule 200 mg (ANDA)
|
Apotex Corp. |
Celecoxib |
D00567
|
|
Cetirizine hydrochloride solution 5 mg/5mL (ANDA)
|
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. |
Cetirizine hydrochloride |
D00664
|
Prednisone tablet 5 mg (ANDA)
Prednisone tablet 10 mg (ANDA)
Prednisone tablet 20 mg (ANDA)
|
Actavis Pharma, Inc. |
Prednisone |
D00473
|
|
LYMPHIR injection, powder, lyophilized, for solution 300 ug/2mL (BLA)
|
Citius Pharmaceuticals, Inc. |
denileukin diftitox-cxdl |
D03682
|
|
Sodium sulfate, potassium sulfate and magnesium sulfate solution 1.6 g77mL (ANDA)
|
NorthStar RxLLC |
Sodium sulfate, potassium sulfate and magnesium sulfate |
D11985
|
|
Prednisolone solution 15 mg/5mL (ANDA)
|
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. |
prednisolone oral solution |
D00472
|
|
Permethrin cream 50 mg/g (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
Permethrin |
D05443
|
|
Potassium Chloride tablet, film coated, extended release 750 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Potassium Chloride |
D02060
|
Oxcarbazepine tablet, film coated 150 mg (ANDA)
Oxcarbazepine tablet, film coated 300 mg (ANDA)
Oxcarbazepine tablet, film coated 600 mg (ANDA)
|
American Health Packaging |
Oxcarbazepine |
D00533
|
|
Pravastatin sodium tablet 80 mg (ANDA)
|
Aurobindo Pharma Limited |
Pravastatin sodium |
D00893
|
|
Tranexamic Acid injection, solution 10 mg/mL (ANDA)
|
Nexus Pharmaceuticals LLC |
Tranexamic Acid |
D01136
|
Metoprolol succinate tablet, extended release 25 mg (ANDA)
Metoprolol succinate tablet, extended release 50 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Metoprolol succinate |
D00635
|
|
DAPZURA RT injection, powder, lyophilized, for solution 500 mg0mL (NDA)
|
Baxter Healthcare Corporation |
daptomycin |
D01080
|
|
Lansoprazole capsule, delayed release 30 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
Lansoprazole |
D00355
|
Pravastatin sodium tablet 10 mg (ANDA)
Pravastatin sodium tablet 20 mg (ANDA)
Pravastatin sodium tablet 40 mg (ANDA)
|
Aurobindo Pharma Limited |
Pravastatin sodium |
D00893
|
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)
|
Novadoz Pharmaceuticals LLC |
Rosuvastatin Calcium |
D01915
|
Quetiapine Fumarate tablet, film coated 25 mg (ANDA)
Quetiapine Fumarate tablet, film coated 50 mg (ANDA)
Quetiapine Fumarate tablet, film coated 100 mg (ANDA)
Quetiapine Fumarate tablet, film coated 200 mg (ANDA)
Quetiapine Fumarate tablet, film coated 300 mg (ANDA)
Quetiapine Fumarate tablet, film coated 400 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Quetiapine Fumarate |
D00458
|
|
Cisatracurium Besylate injection 200 mg/20mL (ANDA)
|
Armas Pharmaceuticals |
Cisatracurium Besylate |
D00759
|
|
Sevelamer Hydrochloride tablet, film coated 800 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Sevelamer Hydrochloride |
D01983
|
Envarsus XR tablet, extended release .75 mg (NDA)
Envarsus XR tablet, extended release 1 mg (NDA)
Envarsus XR tablet, extended release 4 mg (NDA)
|
Veloxis Pharmaceuticals, Inc |
Tacrolimus |
D00107
|
|
Hydrocortisone suspension 100 mg/60mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc |
Hydrocortisone |
D00088
|
|
Phentermine hydrochloride tablet 37.5 mg (ANDA)
|
Bryant Ranch Prepack |
phentermine hydrochloride |
D05459
|
|
Meloxicam tablet 15 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Meloxicam |
D00969
|
|
Bupropion Hydrochloride XL tablet, extended release 150 mg (ANDA)
|
Bryant Ranch Prepack |
bupropion hydrochloride |
D00817
|
|
DORZOLAMIDE HYDROCHLORIDE solution 20 mg/mL (ANDA)
|
Advagen Pharma Ltd. |
dorzolamide hydrochloride |
D00653
|
|
Ciclopirox solution 80 mg/mL (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Ciclopirox |
D03488
|
|
Lidocaine injection, solution 20 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE |
D02086
|
|
Potassium Phosphates injection 236 mg/mL (ANDA)
|
Cipla USA Inc. |
Potassium Phosphates |
|
|
DEXMEDETOMIDINE HYDROCHLORIDE injection 4 ug/mL (ANDA)
|
Wilshire Pharmaceuticals, Inc. |
dexmedetomidine hydrochloride |
D01205
|
|
Buspirone HCL tablet 10 mg (ANDA)
|
Direct_Rx |
Buspirone HCL |
D00702
|
|
Metronidazole capsule 375 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
metronidazole |
D00409
|
|
DIETHYLPROPION HYDROCHLORIDE tablet 25 mg (ANDA)
|
Calvin Scott & Co., Inc. |
DIETHYLPROPION HYDROCHLORIDE |
D03801
|
|
thiamine hydrochloride injection, solution 200 mg/2mL (ANDA)
|
Gland Pharma Limited |
thiamine hydrochloride |
D02094
|
|
Diphenhydramine injection, solution 50 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
DIPHENHYDRAMINE HYDROCHLORIDE |
D00669
|
|
Enalapril Maleate tablet 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Enalapril Maleate |
D00621
|