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Details for New Drug Application (NDA): 078962

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NDA 078962 describes BETAXOLOL HYDROCHLORIDE, which is a drug marketed by Teligent Pharma Inc, Epic Pharma, Apotex Inc, Kvk Tech, Akorn, and Wockhardt, and is included in six NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.

Summary for NDA: 078962

Tradename:
BETAXOLOL HYDROCHLORIDE
Applicant:
Kvk Tech
Ingredient:
betaxolol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Ophthalmic Agents

Pharmacology for NDA: 078962

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 078962

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAXOLOL HYDROCHLORIDE
betaxolol hydrochloride
TABLET;ORAL 078962 ANDA KVK-TECH, INC. 10702-013 10702-013-01 100 TABLET, COATED in 1 BOTTLE (10702-013-01)
BETAXOLOL HYDROCHLORIDE
betaxolol hydrochloride
TABLET;ORAL 078962 ANDA KVK-TECH, INC. 10702-014 10702-014-01 100 TABLET, COATED in 1 BOTTLE (10702-014-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 27, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 27, 2008TE:ABRLD:No


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