| Product |
Company |
Generic name |
KEGG DRUG |
|
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
|
|
Oxcarbazepine suspension 300 mg/5mL (ANDA)
|
Kanchan Healthcare Inc |
Oxcarbazepine |
D00533
|
|
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
|
|
Delflex solution 18.4 mg00mL (NDA)
|
Fresenius Medical Care de Mexico, S.A. de C.V. |
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride |
|
|
DELFLEX solution 18.4 mg00mL (NDA)
|
Fresenius Medical Care Renal Therapies Group, LLC |
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride |
|
|
Diclofenac Sodium gel 30 mg/g (ANDA)
|
REMEDYREPACK INC. |
Diclofenac Sodium Topical |
D00904
|
Dapsone tablet 25 mg (ANDA)
Dapsone tablet 100 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Dapsone |
D00592
|
Propranolol Hydrochloride tablet 20 mg (ANDA)
Propranolol Hydrochloride tablet 10 mg (ANDA)
|
Major Pharmaceuticals |
Propranolol Hydrochloride |
D00483
|
|
Hydroxyurea capsule 500 mg (ANDA)
|
Major Pharmaceuticals |
Hydroxyurea |
D00341
|
Divalproex Sodium tablet, delayed release 250 mg (ANDA)
Divalproex Sodium tablet, delayed release 500 mg (ANDA)
|
Major Pharmaceuticals |
Divalproex Sodium |
D00304
|
|
Levetiracetam tablet, film coated 250 mg (ANDA)
|
A-S Medication Solutions |
Levetiracetam |
D00709
|
Methocarbamol tablet 500 mg (ANDA)
Methocarbamol tablet 750 mg (ANDA)
|
Cardinal Health 107, LLC |
Methocarbamol |
D00402
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 1.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 2.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 3.75 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 6.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 7.5 mg (ANDA)
|
Elite Laboratories, Inc. |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
D11624
|
|
Leuprolide Acetate kit (ANDA)
|
NorthStar RxLLC |
Leuprolide Acetate |
D00989
|
Liomny tablet 5 ug (ANDA)
Liomny tablet 25 ug (ANDA)
Liomny tablet 50 ug (ANDA)
|
SIGMAPHARM LABORATORIES, LLC |
Liothyronine Sodium |
D01011
|
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)
|
Elite Laboratories, Inc. |
lisdexamfetamine dimesylate |
D04747
|
Dabigatran Etexilate capsule 75 mg (ANDA)
Dabigatran Etexilate capsule 150 mg (ANDA)
Dabigatran Etexilate capsule 110 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Dabigatran Etexilate |
D07082
|
|
Oseltamivir phosphate capsule 45 mg (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED |
Oseltamivir phosphate |
D00900
|
|
OXYGEN gas 99 L00L (NDA)
|
Johnson Drug Company, Inc |
OXYGEN |
D00003
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Bryant Ranch Prepack |
Mirtazapine |
D00563
|
|
Nitrogen gas 992 mL/L (NDA)
|
Victor Welding Supply Company |
Nitrogen |
D00083
|