| Product |
Company |
Generic name |
KEGG DRUG |
IVABRADINE tablet, film coated 5 mg (ANDA)
IVABRADINE tablet, film coated 7.5 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC
|
IVABRADINE
|
D08095
|
|
Estradiol gel .75 mg.25g (ANDA)
|
Solaris Pharma Corporation
|
Estradiol
|
D00105
|
|
ziprasidone mesylate injection, powder, lyophilized, for solution 20 mg/mL (ANDA)
|
Gland Pharma Limited
|
ziprasidone mesylate
|
D02100
|
|
Pravastatin Sodium tablet 40 mg (ANDA)
|
REMEDYREPACK INC.
|
Pravastatin Sodium
|
D00893
|
Atazanavir capsule 150 mg (ANDA)
Atazanavir capsule 200 mg (ANDA)
Atazanavir capsule 300 mg (ANDA)
|
Camber Pharmaceuticals, Inc.
|
Atazanavir
|
D01276
|
Darunavir tablet, film coated 600 mg (ANDA)
Darunavir tablet, film coated 800 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC
|
Darunavir
|
D03656
|
Potassium Chloride tablet, extended release 600 mg (ANDA)
Potassium Chloride tablet, extended release 750 mg (ANDA)
|
Upsher-Smith Laboratories, LLC
|
Potassium Chloride
|
D02060
|
|
Primidone tablet 250 mg (ANDA)
|
Actavis Pharma, Inc.
|
Primidone
|
D00474
|
Levetiracetam tablet 250 mg (ANDA)
Levetiracetam tablet 500 mg (ANDA)
Levetiracetam tablet 750 mg (ANDA)
Levetiracetam tablet 1000 mg (ANDA)
|
Tris Pharma Inc
|
Levetiracetam
|
D00709
|
|
Lacosamide solution 10 mg/mL (ANDA)
|
Camber Pharmaceuticals, Inc.
|
Lacosamide
|
D07299
|
Cisatracurium Besylate injection 2 mg/mL (ANDA)
Cisatracurium Besylate injection 10 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc.
|
Cisatracurium Besylate
|
D00759
|
STELARA injection, solution 45 mg/.5mL (BLA)
STELARA injection, solution 90 mg/mL (BLA)
Stelara solution 130 mg/26mL (BLA)
|
Janssen Biotech, Inc.
|
ustekinumab
|
D09214
|
TOUJEO injection, solution 300 U/mL (BLA)
TOUJEO Max injection, solution 300 U/mL (BLA)
|
Sanofi-Aventis U.S. LLC
|
insulin glargine
|
D03250
|
Losartan Potassium tablet 25 mg (ANDA)
Losartan Potassium tablet 50 mg (ANDA)
Losartan Potassium tablet 100 mg (ANDA)
|
Granules India Ltd
|
Losartan
|
D00357
|
Sulfamethoxazole and Trimethoprim tablet 400 mg (ANDA)
Sulfamethoxazole and Trimethoprim tablet 800 mg (ANDA)
|
Aurobindo Pharma Limited
|
Sulfamethoxazole and Trimethoprim
|
D00285
|
|
Formoterol Fumarate solution 20 ug/2mL (ANDA)
|
Ingenus Pharmaceuticals, LLC
|
Formoterol Fumarate
|
D01373
|
Frindovyx injection 500 mg/mL (NDA)
Frindovyx injection 1 g/2mL (NDA)
Frindovyx injection 2 g/4mL (NDA)
|
Avyxa Pharma, LLC
|
Cyclophosphamide
|
D00287
|
|
Diclofenac Potassium capsule, liquid filled 25 mg (NDA AUTHORIZED GENERIC)
|
Leading Pharma, LLC
|
Diclofenac Potassium
|
D00903
|
Olmesartan Medoxomil and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Olmesartan Medoxomil and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Aurobindo Pharma Limited
|
Olmesartan Medoxomil and Hydrochlorothiazide
|
D10284
|
|
RYONCIL kit (BLA)
|
Mesoblast
|
remestemcel-l-rknd
|
D09719
|
|
Diclofenac Sodium Delayed Release tablet, delayed release 75 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Diclofenac Sodium
|
D00904
|
Meloxicam tablet 7.5 mg (ANDA)
Meloxicam tablet 15 mg (ANDA)
|
Aurobindo Pharma Limited
|
Meloxicam
|
D00969
|
Divalproex Sodium tablet, delayed release 250 mg (ANDA)
Divalproex Sodium tablet, delayed release 500 mg (ANDA)
Divalproex Sodium tablet, delayed release 125 mg (ANDA)
|
Aurobindo Pharma Limited
|
Divalproex Sodium
|
D00304
|
Amlodipine Besylate tablet 2.5 mg (ANDA)
Amlodipine Besylate tablet 5 mg (ANDA)
Amlodipine Besylate tablet 10 mg (ANDA)
|
Lupin Pharmaceuticals, Inc.
|
Amlodipine Besylate
|
D00615
|
|
Betamethasone Dipropionate ointment, augmented .5 mg/g (ANDA)
|
A-S Medication Solutions
|
betamethasone dipropionate
|
D01637
|
Primidone tablet 250 mg (ANDA)
Primidone tablet 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Primidone
|
D00474
|
|
BUPROPION HYDROCHLORIDE tablet, extended release 150 mg (ANDA)
|
REMEDYREPACK INC.
|
BUPROPION HYDROCHLORIDE
|
D00817
|
|
Fenofibrate tablet 160 mg (ANDA)
|
Major Pharmaceuticals
|
Fenofibrate
|
D00565
|
|
Diazepam solution 5 mg/5mL (ANDA)
|
Major Pharmaceuticals
|
Diazepam
|
D00293
|
|
Scopolamine Trandermal System patch, extended release 1 mg (ANDA)
|
Bryant Ranch Prepack
|
scolopamine transdermal system
|
D00138
|
Carbidopa and Levodopa tablet, extended release 25 mg (ANDA)
Carbidopa and Levodopa tablet, extended release 50 mg (ANDA)
|
American Health Packaging
|
Carbidopa and Levodopa
|
D00253
|
|
Prednisone tablet 5 mg (ANDA)
|
REMEDYREPACK INC.
|
Prednisone
|
D00473
|
Nortrel 21 Day tablet .035 mg (ANDA)
Nortrel 28 Day kit (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Norethindrone and Ethinyl Estradiol
|
D04483
|
|
Leuprolide Acetate kit (ANDA)
|
Avenacy Inc.
|
leuprolide acetate
|
D00989
|
Nadolol tablet 20 mg (ANDA)
Nadolol tablet 40 mg (ANDA)
Nadolol tablet 80 mg (ANDA)
|
BluePoint Laboratories
|
Nadolol
|
D00432
|
|
Mercaptopurine tablet 50 mg (ANDA)
|
Mylan Pharmaceuticals Inc.
|
mercaptopurine
|
D00161
|
|
Cefuroxime axetil tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Cefuroxime axetil
|
D00914
|
|
IZERVAY injection 20 mg/mL (NDA)
|
Astellas Pharma US, Inc.
|
avacincaptad pegol
|
D11748
|
Amitiza capsule, gelatin coated 8 ug (NDA)
Amitiza capsule, gelatin coated 24 ug (NDA)
|
SpecGx LLC
|
lubiprostone
|
D04790
|
Divalproex Sodium tablet, film coated, extended release 250 mg (ANDA)
Divalproex Sodium tablet, film coated, extended release 500 mg (ANDA)
|
BluePoint Laboratories
|
Divalproex Sodium
|
D00304
|