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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 065137

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NDA 065137 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Lupin Ltd, Mpp Pharma, Ranbaxy, Sunshine, Alembic, Aurobindo, Chartwell, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Jubilant Cadista, Novitium Pharma, Pharmobedient, Teva, and Wockhardt, and is included in twenty-three NDAs. It is available from twenty-seven 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for 065137

Tradename:	CLARITHROMYCIN
Applicant:	Ivax Sub Teva Pharms
Ingredient:	clarithromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065137

Anti-Bacterial Agents
Cytochrome P-450 CYP3A Inhibitors
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 31, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 31, 2005	TE:		RLD:	No

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