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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 065194

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NDA 065194 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 065194

Tradename:	CLINDAMYCIN HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	clindamycin hydrochloride
Patents:	0

Pharmacology for NDA: 065194

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 065194

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	065194	ANDA	Amneal Pharmaceuticals NY LLC	69238-2121	69238-2121-3	3 BLISTER PACK in 1 CARTON (69238-2121-3) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 22, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Mar 22, 2004	TE:	AB	RLD:	No

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