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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 063029

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NDA 063029 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Micro Labs, Pharmobedient, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from thirty-three suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

The generic ingredient in CLINDAMYCIN HYDROCHLORIDE is clindamycin hydrochloride. There are fifty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.

Summary for 063029

Tradename:	CLINDAMYCIN HYDROCHLORIDE
Applicant:	Cosette
Ingredient:	clindamycin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Sep 20, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Aug 5, 2005	TE:		RLD:	No

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