| Product |
Company |
Generic name |
KEGG DRUG |
|
atomoxetine capsule 60 mg (ANDA)
|
Bryant Ranch Prepack |
atomoxetine |
D02574
|
Varenicline tablet, film coated .5 mg (ANDA)
Varenicline tablet, film coated 1 mg (ANDA)
Varenicline kit (ANDA)
|
Par Health USA, LLC |
varenicline tartrate |
D06282
|
Azilsartan medoxomil tablet 40 mg (ANDA)
Azilsartan medoxomil tablet 80 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Azilsartan medoxomil |
D08865
|
Sumatriptan tablet 25 mg (ANDA)
Sumatriptan tablet 50 mg (ANDA)
Sumatriptan tablet 100 mg (ANDA)
|
Aurobindo Pharma Limited |
Sumatriptan Succinate |
D00676
|
|
ATOVAQUONE suspension 750 mg/5mL (ANDA)
|
Amneal Pharmaceuticals LLC |
ATOVAQUONE |
D00236
|
|
Gabapentin capsule 300 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Gabapentin |
D00332
|
|
Brimonidine Tartrate/Timolol Maleate solution/ drops 2 mg/mL (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Brimonidine Tartrate and Timolol Maleate |
D10298
|
Adzenys XR-ODT tablet, orally disintegrating 18.8 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 3.1 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 6.3 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 9.4 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 12.5 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 15.7 mg (NDA)
|
Neos Therapeutics Brands, LLC |
Amphetamine |
D07445
|
LISDEXAMFETAMINE DIMESYLATE capsule 10 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 20 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 30 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 40 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 50 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 60 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 70 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
LISDEXAMFETAMINE DIMESYLATE |
D04747
|
celecoxib capsule 50 mg (ANDA)
celecoxib capsule 100 mg (ANDA)
celecoxib capsule 200 mg (ANDA)
celecoxib capsule 400 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
celecoxib |
D00567
|
|
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
|
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 26.1 mg (NDA)
AZSTARYS capsule 39.2 mg (NDA)
AZSTARYS capsule 52.3 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
|
|
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
|
|
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
|