Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202710

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NDA 202710 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Lupin, 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-six suppliers. Additional details are available on the CLARITHROMYCIN profile page.

The generic ingredient in CLARITHROMYCIN is clarithromycin. There is one drug master file entry for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for 202710

Tradename:	CLARITHROMYCIN
Applicant:	Novitium Pharma
Ingredient:	clarithromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 202710

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jun 10, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 10, 2013	TE:	AB	RLD:	No

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