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Last Updated: December 23, 2024

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, and Norvium Bioscience, 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. Six 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
Ingredient:acebutolol hydrochloride
Patents:0
Pharmacology for NDA: 074007
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 074007
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074007 ANDA Golden State Medical Supply, Inc. 51407-666 51407-666-01 100 CAPSULE in 1 BOTTLE (51407-666-01)
ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074007 ANDA Golden State Medical Supply, Inc. 51407-667 51407-667-01 100 CAPSULE in 1 BOTTLE (51407-667-01)

Profile for product number 001

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

Profile for product number 002

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

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