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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Army
Federal Trade Commission
Healthtrust
Chinese Patent Office
Daiichi Sankyo
Merck
Baxter
Colorcon

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065145

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NDA 065145 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Allied Pharma Inc, Ani Pharms Inc, Lupin Ltd, Mayne Pharma, Ranbaxy, Apotex Corp, Aurobindo, Hec Pharm Usa Inc, Ivax Sub Teva Pharms, Mylan, Teva, West-ward Pharms Int, and Wockhardt, and is included in twenty NDAs. It is available from thirty-eight suppliers. Additional details are available on the CLARITHROMYCIN profile page.

The generic ingredient in CLARITHROMYCIN 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 065145
Tradename:CLARITHROMYCIN
Applicant:Actavis Labs Fl Inc
Ingredient:clarithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065145
Suppliers and Packaging for NDA: 065145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN clarithromycin TABLET, EXTENDED RELEASE;ORAL 065145 ANDA Actavis Pharma, Inc. 0591-2805 N 0591-2805-60
CLARITHROMYCIN clarithromycin TABLET, EXTENDED RELEASE;ORAL 065145 ANDA AvKARE, Inc. 42291-263 N 42291-263-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jun 24, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKinsey
Healthtrust
McKesson
AstraZeneca
Teva
Fish and Richardson
US Department of Justice
Farmers Insurance

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