| Product |
Company |
Generic name |
KEGG DRUG |
|
TOFACITINIB tablet, extended release 11 mg (ANDA)
|
Aurobindo Pharma Limited |
TOFACITINIB |
D09783
|
|
Arepanrix kit (BLA)
|
GlaxoSmithKline Biologicals SA |
Influenza A H5 Monovalent Vaccine |
|
|
fludrocortisone acetate tablet .1 mg (ANDA)
|
Eywa Pharma Inc |
fludrocortisone acetate |
D00986
|
|
Calcium Gluconate injection, solution 100 mg/mL (ANDA)
|
Caplin Steriles Limited |
Calcium Gluconate |
D05463
|
Rocuronium Bromide injection, solution 50 mg/5mL (ANDA)
Rocuronium Bromide injection, solution 100 mg0mL (ANDA)
|
Shandong New Time Pharmaceutical Co., Ltd. |
Rocuronium Bromide |
D00765
|
Lamotrigine tablet, orally disintegrating 25 mg (ANDA)
Lamotrigine tablet, orally disintegrating 50 mg (ANDA)
Lamotrigine tablet, orally disintegrating 100 mg (ANDA)
Lamotrigine tablet, orally disintegrating 200 mg (ANDA)
Lamotrigine kit (ANDA)
|
Par Health USA, LLC |
Lamotrigine |
D00354
|
AZSTARYS capsule 5.2 mg (NDA)
AZSTARYS capsule 7.8 mg (NDA)
AZSTARYS capsule 10.4 mg (NDA)
|
Commave Sub, LLC |
Serdexmethylphenidate and Dexmethylphenidate |
D11989
|
ICOSAPENT ETHYL capsule .5 g (ANDA)
ICOSAPENT ETHYL capsule 1 g (ANDA)
|
XLCare Pharmaceuticals, Inc. |
Icosapent ethyl |
D01892
|
|
Hydrocortisone cream 25 mg/g (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Hydrocortisone |
D00088
|
|
Metoprolol Succinate tablet, film coated, extended release 25 mg (ANDA)
|
Cardinal Health 107, LLC |
Metoprolol Succinate |
D00635
|
|
Hydrocortisone cream 25 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
Hydrocortisone |
D00088
|
Heparin Sodium injection, solution 10000 [USP'U]00mL (NDA)
Heparin Sodium injection, solution 5000 [USP'U]00mL (NDA)
|
Hospira, Inc. |
HEPARIN SODIUM |
D02112
|
|
Hydrocortisone cream 25 mg/g (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Hydrocortisone |
D00088
|
|
LACOSAMIDE injection 10 mg/mL (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Lacosamide |
D07299
|
Dopamine Hydrochloride in Dextrose injection, solution 1.6 mg/mL (NDA)
Dopamine Hydrochloride in Dextrose injection, solution 3.2 mg/mL (NDA)
|
Hospira, Inc. |
Dopamine Hydrochloride in Dextrose |
D00633
|
ISOSORBIDE MONONITRATE tablet, extended release 30 mg (ANDA)
ISOSORBIDE MONONITRATE tablet, extended release 60 mg (ANDA)
ISOSORBIDE MONONITRATE tablet, extended release 120 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
ISOSORBIDE MONONITRATE |
D00630
|
|
HYDROCORTISONE tablet 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
hydrocortisone |
D00088
|
|
Spironolactone and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
spironolactone and hydrochlorothiazide |
D10270
|
|
Celecoxib capsule 200 mg (ANDA)
|
Northwind Health Company, LLC |
Celecoxib |
D00567
|
|
Phentermine Hydrochloride tablet 37.5 mg (ANDA)
|
A-S Medication Solutions |
Phentermine Hydrochloride |
D05459
|
|
Quetiapine Fumarate tablet, film coated 200 mg (ANDA)
|
A-S Medication Solutions |
Quetiapine |
D00458
|
|
Metoprolol succinate tablet, film coated, extended release 50 mg (ANDA)
|
A-S Medication Solutions |
Metoprolol succinate |
D00635
|
|
Rivaroxaban tablet 2.5 mg (ANDA)
|
Dr.Reddy's Laboratories, Inc. |
Rivaroxaban |
D07086
|
|
Calcium Gluconate injection, solution 100 mg/mL (NDA)
|
WG Critical Care, LLC |
Calcium Gluconate |
D05463
|
|
Siliq injection 210 mg (BLA)
|
Bausch Health US LLC |
Brodalumab |
D10061
|
|
Valacyclovir Hydrochloride tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Valacyclovir Hydrochloride |
D00398
|
Vyndaqel capsule, liquid filled 20 mg (NDA)
Vyndamax capsule, liquid filled 61 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
tafamidis meglumine |
D09674
|
|
Diazepam tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
Diazepam |
D00293
|
|
Fluocinonide solution .5 mg/mL (ANDA)
|
Saptalis Pharmaceuticals, LLC. |
Fluocinonide |
D00325
|
|
Tetracycline Hydrochloride capsule 500 mg (ANDA)
|
Bryant Ranch Prepack |
Tetracycline Hydrochloride |
D02122
|
|
Cisatracurium Besylate injection 2 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Cisatracurium Besylate |
D00759
|
Albuterol Sulfate solution 1.25 mg/3mL (ANDA)
Albuterol Sulfate solution .63 mg/3mL (ANDA)
|
Nephron Pharmaceuticals Corporation |
Albuterol Sulfate |
D00683
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 1000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 10000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 5000 [USP'U]/.5mL (NDA)
Heparin Sodium injection, solution 20000 [USP'U]/mL (NDA)
|
Fresenius Kabi USA, LLC |
HEPARIN SODIUM |
D02112
|
RASAGILINE tablet 1 mg (ANDA)
RASAGILINE tablet .5 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
RASAGILINE |
D02562
|
Methylphenidate solution 5 mg/5mL (ANDA)
Methylphenidate solution 10 mg/5mL (ANDA)
|
KVK-Tech, Inc. |
Methylphenidate Hydrochloride |
D01296
|
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
|