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Generated: September 24, 2018

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Details for New Drug Application (NDA): 065136

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NDA 065136 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-six 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-six suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 065136
Tradename:CLARITHROMYCIN
Applicant:Sandoz
Ingredient:clarithromycin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065136
Suppliers and Packaging for NDA: 065136
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN clarithromycin TABLET;ORAL 065136 ANDA Sandoz Inc 0781-1962 0781-1962-60 60 TABLET in 1 BOTTLE (0781-1962-60)
CLARITHROMYCIN clarithromycin TABLET;ORAL 065136 ANDA Rebel Distributors Corp. 21695-558 21695-558-10 10 TABLET in 1 BOTTLE (21695-558-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 25, 2005TE:ABRLD:No

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