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Serving 500+ biopharmaceutical companies globally:

Queensland Health
McKinsey
Citi
QuintilesIMS
Chubb
Farmers Insurance
McKesson
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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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
acebutolol hydrochloride
CAPSULE;ORAL 075047 ANDA Major Pharmaceuticals 0904-6173 0904-6173-60 100 CAPSULE in 1 BOTTLE (0904-6173-60)
ACEBUTOLOL HYDROCHLORIDE
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:

AstraZeneca
Fish and Richardson
Federal Trade Commission
US Army
Julphar
Express Scripts
Johnson and Johnson
Cantor Fitzgerald
Novartis
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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