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Generated: December 13, 2018

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Details for New Drug Application (NDA): 075047

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NDA 075047 describes ACEBUTOLOL HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Mylan, and Watson Labs, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ACEBUTOLOL HYDROCHLORIDE profile page.

The generic ingredient in ACEBUTOLOL HYDROCHLORIDE is acebutolol hydrochloride. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
Summary for 075047
Tradename:ACEBUTOLOL HYDROCHLORIDE
Applicant:Amneal Pharm
Ingredient:acebutolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075047
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075047
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 075047 ANDA Marlex Pharmaceuticals Inc 10135-630 10135-630-01 100 CAPSULE in 1 BOTTLE (10135-630-01)
ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 075047 ANDA Marlex Pharmaceuticals Inc 10135-631 10135-631-01 100 CAPSULE in 1 BOTTLE (10135-631-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Dec 30, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Dec 30, 1999TE:ABRLD:No

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