| Product |
Company |
Generic name |
KEGG DRUG |
|
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
|
|
Irbesartan and Hydrochlorothiazide tablet 12.5 mg (ANDA)
|
Solco Healthcare US, LLC |
Irbesartan and Hydrochlorothiazide |
D10249
|
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 5 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
|
Gvoke HypoPen 0.5 mg Auto-Injector injection, solution .5 mg/.1mL (NDA)
Gvoke HypoPen 1 mg Auto-Injector injection, solution 1 mg/.2mL (NDA)
Gvoke PFS 1 mg Pre-filled Syringe injection, solution 1 mg/.2mL (NDA)
Gvoke Kit injection, solution 1 mg/.2mL (NDA)
|
Xeris Pharmaceuticals, Inc. |
glucagon injection, solution |
D00116
|
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
|
DARZALEX injection, solution, concentrate 100 mg/5mL (BLA)
Darzalex IV injection, solution, concentrate 100 mg/5mL (BLA)
|
Janssen Biotech, Inc. |
Daratumumab |
D10777
|
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
|
|
TECELRA injection, suspension 10000000000 1 (BLA)
|
USWM, LLC |
afamitresgene autoleucel |
D12951
|
|
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
|
|
Rocklatan solution/ drops .05 mg/mL (NDA)
|
Alcon Laboratories, Inc. |
netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% |
D11558
|
|
Lucemyra tablet, film coated .2 mg (NDA)
|
USWM, LLC |
lofexidine hydrochloride |
D04765
|
|
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
|
Buprenorphine patch, extended release 5 ug/h (ANDA)
Buprenorphine patch, extended release 10 ug/h (ANDA)
Buprenorphine patch, extended release 15 ug/h (ANDA)
Buprenorphine patch, extended release 20 ug/h (ANDA)
Buprenorphine patch, extended release 7.5 ug/h (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Buprenorphine |
D07132
|
|
Helium gas 999 mL/L (NDA)
|
NexAir, LLC |
Helium |
D04420
|
|
SPIRONOLACTONE tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
SPIRONOLACTONE |
D00443
|
Azithromycin powder, for suspension 100 mg/5mL (ANDA)
Azithromycin powder, for suspension 200 mg/5mL (ANDA)
|
AiPing Pharmaceutical, Inc. |
Azithromycin |
D02134
|
Ampicillin and Sulbactam injection, powder, for solution 1 g (ANDA)
Ampicillin and Sulbactam injection, powder, for solution 2 g (ANDA)
|
Hospira, Inc |
Ampicillin sodium and Sulbactam sodium |
D02065
|
|
ACETAMINOPHEN AND CODEINE PHOSPHATE tablet 300 mg (ANDA)
|
A-S Medication Solutions |
acetaminophen and codeine phosphate |
D02146
|