| Product |
Company |
Generic name |
KEGG DRUG |
Fluoxetine capsule 10 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 40 mg (ANDA)
|
Aurobindo Pharma Limited |
Fluoxetine Hydrochloride |
D00823
|
|
YONDELIS injection, powder, lyophilized, for solution .05 mg/mL (NDA)
|
Janssen Products, LP |
Trabectedin |
D06199
|
tacrolimus capsule .5 mg (ANDA)
tacrolimus capsule 1 mg (ANDA)
tacrolimus capsule 5 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
tacrolimus |
D00107
|
|
Diclofenac Sodium tablet, delayed release 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Diclofenac Sodium |
D00904
|
Cyclophosphamide injection, powder, for solution 500 mg/25mL (ANDA)
Cyclophosphamide injection, powder, for solution 1 g/50mL (ANDA)
Cyclophosphamide injection, powder, for solution 2 g00mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Cyclophosphamide |
D00287
|
|
AMPYRA tablet, film coated, extended release 10 mg (NDA)
|
Merz Pharmaceuticals, LLC |
Dalfampridine |
D04127
|
|
Oxycodone Hydrochloride capsule 5 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Oxycodone Hydrochloride |
D00847
|
|
Rosuvastatin Calcium tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Rosuvastatin Calcium |
D01915
|
|
Cefazolin injection, powder, for solution 1 g (ANDA)
|
Hospira, Inc |
Cefazolin |
D00905
|
Benazepril Hydrochloride tablet, film coated 10 mg (ANDA)
Benazepril Hydrochloride tablet, film coated 20 mg (ANDA)
Benazepril Hydrochloride tablet, film coated 40 mg (ANDA)
|
Aurobindo Pharma Limited |
Benazepril Hydrochloride |
D00620
|
|
Oxycodone Hydrochloride solution 5 mg/5mL (ANDA)
|
Eywa Pharma Inc |
Oxycodone Hydrochloride |
D00847
|
|
Dovato tablet, film coated 50 mg (NDA)
|
ViiV Healthcare Company |
dolutegravir sodium and lamivudine |
D11522
|
|
FLUOROURACIL injection, solution 50 mg/mL (ANDA)
|
Eugia US LLC |
FLUOROURACIL |
D00584
|
|
Baclofen tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Baclofen |
D00241
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
Trazodone Hydrochloride tablet 100 mg (ANDA)
Trazodone Hydrochloride tablet 150 mg (ANDA)
Trazodone Hydrochloride tablet 300 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Trazodone Hydrochloride |
D00820
|
Glatiramer Acetate injection, solution 20 mg/mL (ANDA)
Glatiramer Acetate injection, solution 40 mg/mL (ANDA)
|
UPSHER-SMITH LABORATORIES, LLC |
Glatiramer Acetate Injection |
D04318
|
Buprenorphine and Naloxone film, soluble 2 mg (ANDA)
Buprenorphine and Naloxone film, soluble 8 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Buprenorphine and Naloxone |
D10250
|
|
HAILEY Fe 1/20 kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
norethindrone acetate and ethinyl estradiol and ferrous fumarate |
D04483
|
Buprenorphine and Naloxone film, soluble 4 mg (ANDA)
Buprenorphine and Naloxone film, soluble 12 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Buprenorphine and Naloxone |
D10250
|
Daptomycin injection, powder, lyophilized, for solution 500 mg0mL (NDA)
Daptomycin injection, powder, lyophilized, for solution 350 mg/7mL (NDA)
|
Hikma Pharmaceuticals USA Inc. |
daptomycin |
D01080
|
Tracleer tablet, film coated 62.5 mg (NDA)
Tracleer tablet, film coated 125 mg (NDA)
Tracleer tablet, for suspension 32 mg (NDA)
|
Actelion Pharmaceuticals US, Inc. |
bosentan |
D01227
|
|
Promethazine Hydrochloride injection 25 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Promethazine Hydrochloride |
D00480
|
|
Rhopressa solution/ drops .2 mg/mL (NDA)
|
Alcon Laboratories, Inc. |
netarsudil |
D11031
|
Lidocaine Hydrochloride and Dextrose injection, solution .4 g00mL (NDA)
Lidocaine Hydrochloride and Dextrose injection, solution .8 g00mL (NDA)
|
B. Braun Medical Inc. |
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE |
|
|
GABAPENTIN capsule 100 mg (ANDA)
|
A-S Medication Solutions |
gabapentin |
D00332
|
|
VYTORIN tablet 10 mg (NDA)
|
Organon LLC |
ezetimibe and simvastatin |
D10257
|
|
VALGANCICLOVIR HYDROCHLORIDE tablet 450 mg (ANDA)
|
Aurobindo Pharma Limited |
VALGANCICLOVIR HYDROCHLORIDE |
D03256
|
|
LIRAGLUTIDE injection, solution 6 mg/mL (ANDA)
|
Cipla USA Inc. |
LIRAGLUTIDE |
D06404
|
|
Cathflo Activase injection, powder, lyophilized, for solution 2.2 mg/2mL (BLA)
|
Genentech, Inc. |
Alteplase |
D02837
|
Atenolol tablet 25 mg (ANDA)
Atenolol tablet 50 mg (ANDA)
Atenolol tablet 100 mg (ANDA)
|
Ipca Laboratories Limited |
Atenolol |
D00235
|
|
Metronidazole tablet 500 mg (ANDA)
|
Cardinal Health 107, LLC |
Metronidazole |
D00409
|
|
Paclitaxel injection, solution 6 mg/mL (ANDA)
|
Natco Pharma USA LLC |
Paclitaxel |
D00491
|
|
Sucralfate tablet 1 g (ANDA)
|
Preferred Pharmaceuticals Inc |
Sucralfate |
D00446
|
Atropine Sulfate injection .4 mg/mL (ANDA)
Atropine Sulfate injection 1 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Atropine Sulfate |
D02069
|
|
DOXYCYCLINE capsule 40 mg (ANDA)
|
AiPing Pharmaceutical, Inc. |
DOXYCYCLINE |
D00307
|
|
Inbrija capsule 42 mg (NDA)
|
Merz Pharmaceuticals, LLC |
levodopa |
D00059
|
|
Betamethasone Dipropionate cream .5 mg/g (ANDA)
|
Actavis Pharma, Inc. |
Betamethasone Dipropionate |
D01637
|
|
Duloxetine capsule, delayed release 40 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Duloxetine |
D01179
|
|
Venlafaxine Hydrochloride capsule, extended release 150 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Venlafaxine Hydrochloride |
D00821
|
Omeprazole capsule, delayed release 10 mg (ANDA)
Omeprazole capsule, delayed release 20 mg (ANDA)
Omeprazole capsule, delayed release 40 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Omeprazole |
D00455
|