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Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075386

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NDA 075386 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 075386
Ingredient:betaxolol hydrochloride
Therapeutic Class:Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075386
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 075386
Suppliers and Packaging for NDA: 075386
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075386 ANDA Akorn, Inc. 17478-705 N 17478-705-11
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075386 ANDA Akorn, Inc. 17478-705 N 17478-705-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Jun 30, 2000TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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Fish and Richardson
Boehringer Ingelheim

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