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Generated: December 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065178

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NDA 065178 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Allied, Ani Pharms Inc, Lupin Ltd, Mayne Pharma, Ranbaxy, Sunshine Lake, Allied Pharma Inc, Apotex Corp, Aurobindo, Hec Pharm, Ivax Sub Teva Pharms, Mylan, Teva, West-ward Pharms Int, and Wockhardt, and is included in twenty-one NDAs. It is available from thirty-five 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-five suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 065178
Tradename:CLARITHROMYCIN
Applicant:West-ward Pharms Int
Ingredient:clarithromycin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065178
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN clarithromycin TABLET;ORAL 065178 ANDA West-Ward Pharmaceuticals Corp. 0054-0036 0054-0036-21 60 TABLET, COATED in 1 BOTTLE, PLASTIC (0054-0036-21)
CLARITHROMYCIN clarithromycin TABLET;ORAL 065178 ANDA West-Ward Pharmaceuticals Corp. 0054-0037 0054-0037-21 60 TABLET, COATED in 1 BOTTLE, PLASTIC (0054-0037-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 25, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:May 25, 2004TE:ABRLD:No

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