Last Updated: August 25, 2026

Details for New Drug Application (NDA): 091225

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NDA 091225 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 are fifty-five drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.

Summary for 091225

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	May 31, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	May 31, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	May 31, 2011	TE:		RLD:	No

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