Details for New Drug Application (NDA): 050162

NDA 050162 describes CLEOCIN HYDROCHLORIDE, which is a drug marketed by Pfizer and is included in one NDA. It is available from four suppliers. Additional details are available on the CLEOCIN HYDROCHLORIDE profile page.

The generic ingredient in CLEOCIN 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 050162

Tradename:	CLEOCIN HYDROCHLORIDE
Applicant:	Pfizer
Ingredient:	clindamycin hydrochloride
Patents:	0

Pharmacology for NDA: 050162

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 050162

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA	Pharmacia & Upjohn Company LLC	0009-0225	0009-0225-02	100 CAPSULE in 1 BOTTLE (0009-0225-02)
CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA	Pharmacia & Upjohn Company LLC	0009-0331	0009-0331-02	100 CAPSULE in 1 BOTTLE (0009-0331-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Apr 14, 1988	TE:	AB	RLD:	Yes

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