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Last Updated: April 1, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074007


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NDA 074007 describes ACEBUTOLOL HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Ani Pharms Inc, and Mylan, and is included in three NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
Summary for 074007
Tradename:ACEBUTOLOL HYDROCHLORIDE
Applicant:Ani Pharms Inc
Ingredient:acebutolol hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Oct 18, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Oct 18, 1995TE:RLD:No

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