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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cerilliant
Citi
Fish and Richardson
Cipla
Dow
Queensland Health
Express Scripts
Harvard Business School

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050698

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NDA 050698 describes BIAXIN, which is a drug marketed by Abbvie and is included in three NDAs. It is available from one supplier. Additional details are available on the BIAXIN profile page.

The generic ingredient in BIAXIN is clarithromycin. There are twenty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 050698
Tradename:BIAXIN
Applicant:Abbvie
Ingredient:clarithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 050698
Suppliers and Packaging for NDA: 050698
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIAXIN clarithromycin FOR SUSPENSION;ORAL 050698 NDA Physicians Total Care, Inc. 54868-3384 E 54868-3384-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Dec 23, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Dec 23, 1993TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength187MG/5ML
Approval Date:Sep 30, 1998TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Harvard Business School
Boehringer Ingelheim
Citi
QuintilesIMS
Farmers Insurance
Dow
Merck

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