| Product |
Company |
Generic name |
KEGG DRUG |
Ambrisentan tablet, film coated 5 mg (ANDA)
Ambrisentan tablet, film coated 10 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
Ambrisentan |
D07077
|
|
Chlordiazepoxide Hydrochloride and Clidinium Bromide capsule 5 mg (ANDA)
|
Winder Laboratories LLC |
Chlordiazepoxide Hydrochloride and Clidinium Bromide |
D10247
|
DEXMEDETOMIDINE HYDROCHLORIDE injection 200 ug/50mL (ANDA)
DEXMEDETOMIDINE HYDROCHLORIDE injection 400 ug00mL (ANDA)
|
Baxter Healthcare Company |
DEXMEDETOMIDINE HYDROCHLORIDE |
D01205
|
VARDENAFIL tablet, film coated 2.5 mg (ANDA)
VARDENAFIL tablet, film coated 5 mg (ANDA)
VARDENAFIL tablet, film coated 10 mg (ANDA)
VARDENAFIL tablet, film coated 20 mg (ANDA)
|
Zydus Lifesciences Limited |
VARDENAFIL |
D03260
|
Oxycodone and Acetaminophen tablet 5 mg (ANDA)
Oxycodone and Acetaminophen tablet 7.5 mg (ANDA)
Oxycodone and Acetaminophen tablet 10 mg (ANDA)
|
Alvogen, Inc. |
Oxycodone and Acetaminophen |
D02153
|
|
bupropion Hydrochloride tablet 100 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
bupropion Hydrochloride |
D00817
|
Glipizide tablet, extended release 2.5 mg (ANDA)
Glipizide tablet, extended release 5 mg (ANDA)
Glipizide tablet, extended release 10 mg (ANDA)
|
Northstar Rx LLC. |
Glipizide |
D00335
|
|
Cetirizine Hydrochloride Oral Solution solution 1 mg/mL (ANDA)
|
APOZEAL PHARMACEUTICALS INC |
Cetirizine Hydrochloride Oral Solution |
D00664
|
|
Cyanocobalamin injection, solution 1000 ug/mL (ANDA)
|
A-S Medication Solutions |
Cyanocobalamin |
D00166
|
|
Lactulose solution 10 g5mL (ANDA)
|
APOZEAL PHARMACEUTICALS INC |
Lactulose |
D00352
|
|
Clindamycin Phosphate lotion 10 ug/mL (ANDA)
|
Encube Ethicals, Inc. |
Clindamycin Phosphate |
D01073
|
|
Enalapril Maleate tablet 20 mg (ANDA)
|
A-S Medication Solutions |
Enalapril Maleate |
D00621
|
|
Dicyclomine hydrochloride tablet 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Dicyclomine hydrochloride |
D00717
|
|
Doxycycline Hyclate capsule 100 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Doxycycline Hyclate |
D02129
|
XIFAXAN tablet 200 mg (NDA)
XIFAXAN tablet 550 mg (NDA)
|
Salix Pharmaceuticals, Inc. |
rifaximin |
D02554
|
Isosorbide Mononitrate tablet, extended release 120 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 30 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 60 mg (ANDA)
|
Shandong New Time Pharmaceutical Co., Ltd. |
Isosorbide Mononitrate |
D00630
|
|
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% cream .5 mg/g (ANDA)
|
A-S Medication Solutions |
Clobetasol Propionate USP, 0.05% |
D01272
|
|
NITROGEN gas 990 mL/L (NDA)
|
Welders Supply Company |
NITROGEN |
D00083
|
|
Atenolol tablet 50 mg (ANDA)
|
A-S Medication Solutions |
Atenolol |
D00235
|
|
Brompheniramine, Pseudoephedrine, Dextromethorphan syrup 2 mg/5mL (ANDA)
|
Ascend Laboratories, LLC |
Brompheniramine, Pseudoephedrine, Dextromethorphan |
D11647
|
|
Loperamide Hydrochloride capsule 2 mg (ANDA)
|
Advagen Pharma Ltd., |
Loperamide Hydrochloride |
D00729
|
|
Lacosamide injection 10 mg/mL (ANDA)
|
Sintetica US LLC |
lacosamide |
D07299
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
Northwind Health Company, LLC |
Omeprazole |
D00455
|
|
Prochlorperazine Maleate tablet 10 mg (ANDA)
|
Northwind Health Company, LLC |
Prochlorperazine Maleate |
D00479
|
|
Naproxen Sodium tablet 550 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Naproxen Sodium |
D00970
|
|
Potassium Chloride for Oral Solution powder, for solution 1.5 g.58g (ANDA)
|
BPI Labs LLC |
Potassium Chloride for Oral Solution |
D02060
|
|
Fluoxetine Hydrochloride solution 20 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Fluoxetine Hydrochloride |
D00823
|
Lenalidomide capsule 2.5 mg (ANDA)
Lenalidomide capsule 5 mg (ANDA)
Lenalidomide capsule 10 mg (ANDA)
Lenalidomide capsule 15 mg (ANDA)
Lenalidomide capsule 20 mg (ANDA)
Lenalidomide capsule 25 mg (ANDA)
|
Novugen Pharma (USA) LLC |
Lenalidomide |
D04687
|
|
Doxycycline Hyclate tablet 100 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Doxycycline Hyclate |
D02129
|
|
METHSCOPOLAMINE BROMIDE tablet 2.5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
methscopolamine bromide |
D00715
|
|
Megestrol Acetate suspension 40 mg/mL (ANDA)
|
American Health Packaging |
Megestrol Acetate |
D00952
|
ZITUVIMET XR tablet, film coated, extended release 50 mg (NDA)
ZITUVIMET XR tablet, film coated, extended release 100 mg (NDA)
|
Zydus Pharmaceuticals USA Inc. |
sitagliptin and metformin hydrochloride |
D10261
|
|
Dehydrated Alcohol injection, solution 1 mL/mL (NDA)
|
BPI Labs, LLC |
Alcohol |
D00068
|
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
A-S Medication Solutions |
Trazodone Hydrochloride |
D00820
|
|
PRAVASTATIN SODIUM tablet 10 mg (ANDA)
|
A-S Medication Solutions |
PRAVASTATIN SODIUM |
D00893
|
|
Glipizide and Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Glipizide and Metformin Hydrochloride |
D10265
|
|
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE capsule 25 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE |
D11615
|
Fluphenazine hydrochloride tablet 10 mg (ANDA)
Fluphenazine hydrochloride tablet 5 mg (ANDA)
Fluphenazine hydrochloride tablet 2.5 mg (ANDA)
Fluphenazine hydrochloride tablet 1 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Fluphenazine hydrochloride |
D00791
|
|
Diclofenac Sodium Delayed Release tablet, delayed release 50 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Diclofenac Sodium |
D00904
|
ZITUVIMET XR tablet, film coated, extended release 50 mg (NDA)
ZITUVIMET XR tablet, film coated, extended release 100 mg (NDA)
|
Zydus Lifesciences Limited |
sitagliptin and metformin hydrochloride |
D10261
|