Last Updated: September 24, 2026

Details for New Drug Application (NDA): 065217

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NDA 065217 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Cosette Pharms Nc, 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-four suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

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

Summary for 065217

Tradename:	CLINDAMYCIN HYDROCHLORIDE
Applicant:	Zydus Pharms Usa
Ingredient:	clindamycin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Jan 31, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jan 31, 2005	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Jan 31, 2005	TE:	AB	RLD:	No

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