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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
QuintilesIMS
Cantor Fitzgerald
Argus Health
Cipla
Colorcon
Healthtrust
US Army
Express Scripts

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075541

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NDA 075541 describes BETAXOLOL HYDROCHLORIDE, which is a drug marketed by Akorn, Apotex Inc, Medimetriks Pharms, Wockhardt, Epic Pharma, and Kvk Tech, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the BETAXOLOL HYDROCHLORIDE profile page.

The generic ingredient in BETAXOLOL HYDROCHLORIDE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
Summary for 075541
Tradename:BETAXOLOL HYDROCHLORIDE
Applicant:Epic Pharma
Ingredient:betaxolol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075541
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 075541
Suppliers and Packaging for NDA: 075541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 075541 ANDA Marlex Pharmaceuticals Inc 10135-623 10135-623-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-623-01)
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 075541 ANDA Marlex Pharmaceuticals Inc 10135-624 10135-624-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-624-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 22, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 22, 1999TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Cerilliant
Healthtrust
Fuji
Baxter
Novartis
Daiichi Sankyo
Medtronic

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