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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 065250

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NDA 065250 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, Nostrum Labs Inc, Ranbaxy, Sunshine, Ajanta Pharma Ltd, Alembic, Aurobindo, Chartwell, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Norvium Bioscience, Strides Pharma, Teva, and Wockhardt, and is included in twenty-three NDAs. It is available from twenty-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. Twenty-eight suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for 065250

Tradename:	CLARITHROMYCIN
Applicant:	Ani Pharms
Ingredient:	clarithromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065250

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Aug 25, 2005	TE:		RLD:	No

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