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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Moodys
US Army
Fish and Richardson
McKinsey
Express Scripts
Daiichi Sankyo
Citi
Boehringer Ingelheim

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050775

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NDA 050775 describes BIAXIN XL, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the BIAXIN XL profile page.

The generic ingredient in BIAXIN XL is clarithromycin. There are twenty-one drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 050775
Tradename:BIAXIN XL
Applicant:Abbvie
Ingredient:clarithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 050775
Suppliers and Packaging for NDA: 050775
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIAXIN XL clarithromycin TABLET, EXTENDED RELEASE;ORAL 050775 NDA Physicians Total Care, Inc. 54868-4191 E 54868-4191-0
BIAXIN XL clarithromycin TABLET, EXTENDED RELEASE;ORAL 050775 NDA Physicians Total Care, Inc. 54868-4191 E 54868-4191-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 3, 2000TE:RLD:Yes

Expired US Patents for NDA 050775

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie BIAXIN XL clarithromycin TABLET, EXTENDED RELEASE;ORAL 050775-001 Mar 3, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie BIAXIN XL clarithromycin TABLET, EXTENDED RELEASE;ORAL 050775-001 Mar 3, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie BIAXIN XL clarithromycin TABLET, EXTENDED RELEASE;ORAL 050775-001 Mar 3, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
AstraZeneca
Healthtrust
Express Scripts
Baxter
Merck
Johnson and Johnson
Accenture
Boehringer Ingelheim

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