| Product |
Company |
Generic name |
KEGG DRUG |
|
SOTALOL HYDROCHLORIDE tablet 160 mg (ANDA)
|
Bryant Ranch Prepack |
SOTALOL HYDROCHLORIDE |
D01026
|
Tyvaso DPI kit (NDA)
Tyvaso DPI inhalant 16 ug (NDA)
Tyvaso DPI inhalant 32 ug (NDA)
Tyvaso DPI inhalant 48 ug (NDA)
Tyvaso DPI inhalant 64 ug (NDA)
Tyvaso DPI inhalant 80 ug (NDA)
|
United Therapeutics Corporation |
treprostinil |
D06213
|
LUCENTIS injection, solution 10 mg/mL (BLA)
LUCENTIS injection, solution 6 mg/mL (BLA)
|
Genentech, Inc. |
RANIBIZUMAB |
D05697
|
|
Duloxetine capsule, delayed release 30 mg (ANDA)
|
A-S Medication Solutions |
Duloxetine |
D01179
|
|
Phenylephrine hydrochloride injection 10 mg/mL (ANDA)
|
Provepharm Inc. |
Phenylephrine hydrochloride |
D00511
|
|
Duloxetine capsule, delayed release 30 mg (ANDA)
|
A-S Medication Solutions |
Duloxetine |
D01179
|
IMATINIB MESYLATE tablet, film coated 100 mg (ANDA)
IMATINIB MESYLATE tablet, film coated 400 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
IMATINIB MESYLATE |
D01441
|
|
Lupron Depot-PED kit (NDA)
|
AbbVie Inc. |
leuprolide acetate |
D00989
|
|
Oxygen gas 990 mL/L (NDA)
|
MEDICAL-TECHNICAL GASES, INC. |
Oxygen |
D00003
|
|
NITROGEN gas 990 mL/L (NDA)
|
Medical-Technical Gases, Inc. |
NITROGEN |
D00083
|
|
OXYGEN gas 99 L00L (NDA)
|
Greene Respiratory Services, Inc |
OXYGEN |
D00003
|
|
Desoximetasone cream 2.5 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Desoximetasone |
D03697
|
|
oxygen gas 990 mL/L (NDA)
|
A & E Mill & Welding Supply Company |
oxygen |
D00003
|
|
MEMBRANEBLUE injection, solution .75 mg/.5mL (NDA)
|
Dutch Ophthalmic Research Center (International) B.V. |
trypan blue |
D12658
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
Metolazone tablet 10 mg (ANDA)
|
Sandoz Inc |
Metolazone |
D00431
|
Dexmethylphenidate Hydrochloride tablet 2.5 mg (ANDA)
Dexmethylphenidate Hydrochloride tablet 5 mg (ANDA)
Dexmethylphenidate Hydrochloride tablet 10 mg (ANDA)
|
KVK-TECH, INC |
Dexmethylphenidate Hydrochloride |
D03721
|
|
Simvastatin tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Aurobindo Pharma Limited |
Irbesartan |
D00523
|
|
Rosuvastatin tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Rosuvastatin |
D01915
|
|
Anthim solution 100 mg/mL (BLA)
|
Elusys Therapeutics, Inc. |
obiltoxaximab |
D10776
|
|
Potassium chloride tablet, film coated, extended release 750 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Potassium Chloride |
D02060
|
|
Simvastatin tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
isoniazid tablet 300 mg (ANDA)
|
Coupler LLC |
isoniazid |
D00346
|
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
Bryant Ranch Prepack |
Sevelamer Carbonate |
D06642
|
|
Sulfamethoxazole and Trimethoprim tablet 800 mg (ANDA)
|
Cardinal Health 107, LLC |
Sulfamethoxazole and Trimethoprim |
D00285
|
Isosorbide Dinitrate tablet 20 mg (ANDA)
Isosorbide Dinitrate tablet 10 mg (ANDA)
|
Cardinal Health 107, LLC |
Isosorbide Dinitrate |
D00516
|
|
Simvastatin tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Simvastatin tablet, film coated 20 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
Diltiazem Hydrochloride tablet, film coated 30 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 60 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 90 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 120 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Diltiazem Hydrochloride |
D00616
|
|
Simvastatin tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Betamethasone Dipropionate lotion, augmented .5 mg/mL (ANDA)
|
Encube Ethicals, Inc. |
BETAMETHASONE DIPROPIONATE |
D01637
|
|
REDEMPLO injection, solution 25 mg/.5mL (NDA)
|
Arrowhead Pharmaceuticals, Inc. |
plozasiran |
D13206
|
Clonidine Hydrochloride tablet .1 mg (ANDA)
Clonidine Hydrochloride tablet .2 mg (ANDA)
|
Major Pharmaceuticals |
clonidine hydrochloride |
D00604
|
|
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin |
D00229
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
|
Major Pharmaceuticals |
Metolazone |
D00431
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Irbesartan |
D00523
|
|
CALCITONIN SALMON injection, solution 200 [USP'U]/mL (ANDA)
|
Cipla USA Inc. |
CALCITONIN SALMON |
D00249
|
|
Simvastatin tablet, film coated 20 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Sodium Bicarbonate injection, solution 84 mg/mL (ANDA)
|
Civica |
SODIUM BICARBONATE |
D01203
|
|
Simvastatin tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|