Details for New Drug Application (NDA): 065442

NDA 065442 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Micro Labs, Norvium Bioscience, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from thirty-five 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-seven suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.

Summary for 065442

Tradename:	CLINDAMYCIN HYDROCHLORIDE
Applicant:	Aurobindo Pharma
Ingredient:	clindamycin hydrochloride
Patents:	0

Pharmacology for NDA: 065442

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 065442

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	065442	ANDA	Major Pharmaceuticals	0904-7194	0904-7194-61	100 BLISTER PACK in 1 CARTON (0904-7194-61) / 1 CAPSULE in 1 BLISTER PACK
CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	065442	ANDA	A-S Medication Solutions	50090-0443	50090-0443-0	30 CAPSULE in 1 BOTTLE (50090-0443-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Aug 26, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Aug 26, 2009	TE:	AB	RLD:	No

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