| Product |
Company |
Generic name |
KEGG DRUG |
Crestor tablet, film coated 5 mg (NDA)
Crestor tablet, film coated 10 mg (NDA)
Crestor tablet, film coated 20 mg (NDA)
Crestor tablet, film coated 40 mg (NDA)
|
AstraZeneca Pharmaceuticals LP |
Rosuvastatin |
D01915
|
|
Heparin Sodium injection, solution 200 [USP'U]00mL (NDA)
|
Hospira, Inc. |
HEPARIN SODIUM |
D02112
|
FANAPT tablet 1 mg (NDA)
FANAPT tablet 2 mg (NDA)
FANAPT tablet 4 mg (NDA)
FANAPT tablet 6 mg (NDA)
FANAPT tablet 8 mg (NDA)
FANAPT tablet 10 mg (NDA)
FANAPT tablet 12 mg (NDA)
FANAPT kit (NDA)
|
Vanda Pharmaceuticals Inc. |
ILOPERIDONE |
D02666
|
|
LISINOPRIL tablet 10 mg (ANDA)
|
Proficient Rx LP |
Lisinopril |
D00362
|
|
Tropicamide solution/ drops 10 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Tropicamide |
D00397
|
ICOSAPENT ETHYL capsule .5 g (ANDA)
ICOSAPENT ETHYL capsule 1 g (ANDA)
|
Camber Pharmaceuticals, Inc. |
Icosapent ethyl |
D01892
|
|
Fludrocortisone Acetate tablet .1 mg (ANDA)
|
Cardinal Health 107, LLC |
Fludrocortisone Acetate |
D00986
|
capecitabine tablet, film coated 150 mg (ANDA)
capecitabine tablet, film coated 500 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
capecitabine |
D01223
|
|
Primaquine Phosphate tablet 15 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Primaquine Phosphate |
D02126
|
|
Ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
Bryant Ranch Prepack |
Ondansetron |
D00456
|
TAZICEF injection, powder, for solution 1 g (ANDA)
TAZICEF injection, powder, for solution 2 g (ANDA)
|
Hospira, Inc. |
CEFTAZIDIME |
D00921
|
|
Hydroxyzine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Hydroxyzine Hydrochloride |
D00672
|
|
Ganirelix Acetate injection, solution 250 ug/.5mL (ANDA)
|
Mullan Pharmaceutical Inc. |
Ganirelix Acetate |
D04302
|
Simvastatin tablet, film coated 5 mg (ANDA)
Simvastatin tablet, film coated 10 mg (ANDA)
Simvastatin tablet, film coated 20 mg (ANDA)
Simvastatin tablet, film coated 40 mg (ANDA)
Simvastatin tablet, film coated 80 mg (ANDA)
|
Aurobindo Pharma Limited |
Simvastatin |
D00434
|
|
LEUPROLIDE ACETATE kit (ANDA)
|
Eugia US LLC |
LEUPROLIDE ACETATE |
D00989
|
Valacyclovir tablet 500 mg (ANDA)
Valacyclovir tablet 1000 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Valacyclovir |
D00398
|
|
Fluoxetine capsule 20 mg (ANDA)
|
Northwind Health Company, LLC |
Fluoxetine |
D00823
|
Rasagiline tablet .5 mg (ANDA)
Rasagiline tablet 1 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Rasagiline mesylate |
D02562
|
|
NYSTATIN suspension 100000 U/mL (ANDA)
|
Bryant Ranch Prepack |
NYSTATIN |
D00202
|
|
PRAVASTATIN SODIUM tablet 10 mg (ANDA)
|
Northwind Health Company, LLC |
PRAVASTATIN SODIUM |
D00893
|
Dapsone 25mg tablet 25 mg (ANDA)
Dapsone 100mg tablet 100 mg (ANDA)
|
Solis Pharmaceuticals Inc. |
Dapsone 25mg |
D00592
|
|
Fluoxetine capsule 10 mg (ANDA)
|
Northwind Health Company, LLC |
Fluoxetine |
D00823
|
|
PREXXARTAN solution 4 mg/mL (NDA)
|
AptaPharma Inc. |
PREXXARTAN |
D00400
|
|
Lisinopril tablet 20 mg (ANDA)
|
Coupler LLC |
Lisinopril |
D00362
|
|
Olanzapine tablet, film coated 10 mg (ANDA)
|
Coupler LLC |
Olanzapine |
D00454
|
|
LOPERAMIDE HYDROCHLORIDE capsule 2 mg (ANDA)
|
Coupler LLC |
LOPERAMIDE HYDROCHLORIDE |
D00729
|
|
Prazosin Hydrochloride capsule 2 mg (ANDA)
|
Coupler LLC |
Prazosin Hydrochloride |
D00609
|
|
Sertraline Hydrochloride tablet, film coated 50 mg (ANDA)
|
Coupler LLC |
Sertraline Hydrochloride |
D00825
|
|
Sulfamethoxazole and Trimethoprim tablet 800 mg (ANDA)
|
Coupler LLC |
Sulfamethoxazole and Trimethoprim |
D00285
|
|
Nifedipine tablet, film coated, extended release 30 mg (ANDA)
|
Coupler LLC |
nifedipine |
D00437
|
|
Fluconazole tablet 100 mg (ANDA)
|
Coupler LLC |
Fluconazole |
D00322
|
|
HYDROXYZINE HYDROCHLORIDE tablet, film coated 25 mg (ANDA)
|
Coupler LLC |
hydroxyzine hydrochloride |
D00672
|
Ampicillin injection, powder, for solution 250 mg (ANDA)
Ampicillin injection, powder, for solution 500 mg (ANDA)
Ampicillin injection, powder, for solution 1 g (ANDA)
Ampicillin injection, powder, for solution 2 g (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
Ampicillin |
D02119
|
|
Ampicillin injection, powder, for solution 10 g (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
Ampicillin |
D02119
|
Paliperidone tablet, film coated, extended release 3 mg (ANDA)
Paliperidone tablet, film coated, extended release 6 mg (ANDA)
Paliperidone tablet, film coated, extended release 9 mg (ANDA)
|
Major Pharmaceuticals |
Paliperidone |
D05339
|
|
Lidocaine Hydrochloride and Epinephrine injection, solution 5 mg/mL (ANDA)
|
Henry Schein, Inc. |
Lidocaine Hydrochloride and Epinephrine |
D04052
|
|
dexamethasone tablet 4 mg (ANDA)
|
Cardinal Health 107, LLC |
dexamethasone |
D00292
|
OXCARBAZEPINE tablet, film coated 150 mg (ANDA)
OXCARBAZEPINE tablet, film coated 300 mg (ANDA)
OXCARBAZEPINE tablet, film coated 600 mg (ANDA)
|
Major Pharmaceuticals |
OXCARBAZEPINE |
D00533
|
|
HYDROCHLOROTHIAZIDE tablet 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
hydrochlorothiazide |
D00340
|
Carbidopa and levodopa tablet, extended release 25 mg (ANDA)
Carbidopa and levodopa tablet, extended release 50 mg (ANDA)
|
Advagen Pharma Ltd |
Carbidopa and levodopa |
D00253
|