Details for New Drug Application (NDA): 050680

NDA 050680 describes CLEOCIN, which is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in fourteen NDAs. It is available from two suppliers. Additional details are available on the CLEOCIN profile page.

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

Summary for 050680

Tradename:	CLEOCIN
Applicant:	Pfizer
Ingredient:	clindamycin phosphate
Patents:	0

Pharmacology for NDA: 050680

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 050680

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680	NDA	Pharmacia & Upjohn Company LLC	0009-3448	0009-3448-01	1 TUBE, WITH APPLICATOR in 1 CARTON (0009-3448-01) / 40 g in 1 TUBE, WITH APPLICATOR
CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-5009	59762-5009-1	1 TUBE in 1 CARTON (59762-5009-1) / 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;VAGINAL			Strength	EQ 2% BASE
Approval Date:	Aug 11, 1992	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	EQ 2% BASE
Approval Date:	Mar 2, 1998	TE:	AB	RLD:	Yes

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