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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Argus Health
Express Scripts
Harvard Business School

Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075047

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NDA 075047 describes ACEBUTOLOL HYDROCHLORIDE, which is a drug marketed by Watson Labs, Amneal Pharm, and Mylan, and is included in three NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.

Summary for NDA: 075047

Therapeutic Class:Cardiovascular Agents
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
CAPSULE;ORAL 075047 ANDA Major Pharmaceuticals 0904-6173 0904-6173-60 100 CAPSULE in 1 BOTTLE (0904-6173-60)
acebutolol hydrochloride
CAPSULE;ORAL 075047 ANDA AvKARE, Inc. 42291-101 42291-101-90 90 CAPSULE in 1 BOTTLE (42291-101-90)

Summary for product number 001

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

Summary for product number 002

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

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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
US Army
Express Scripts
Johnson and Johnson
Cantor Fitzgerald

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