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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Chinese Patent Office
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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065384

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NDA 065384 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Allied Pharma Inc, Idt Australia Ltd, 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 065384
Applicant:Apotex Corp
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065384
Suppliers and Packaging for NDA: 065384
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN clarithromycin TABLET;ORAL 065384 ANDA Apotex Corp 60505-2615 N 60505-2615-3
CLARITHROMYCIN clarithromycin TABLET;ORAL 065384 ANDA Apotex Corp 60505-2615 N 60505-2615-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 20, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 20, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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US Army
US Department of Justice

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