Details for New Drug Application (NDA): 090902

NDA 090902 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Heritage Pharms Inc, Padagis Us, and Rising, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the CLINDAMYCIN PALMITATE HYDROCHLORIDE profile page.

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

Summary for 090902

Tradename:	CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:	Padagis Us
Ingredient:	clindamycin palmitate hydrochloride
Patents:	0

Pharmacology for NDA: 090902

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 090902

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE	clindamycin palmitate hydrochloride	FOR SOLUTION;ORAL	090902	ANDA	Padagis US LLC	0574-0129	0574-0129-01	1 BOTTLE, GLASS in 1 CARTON (0574-0129-01) / 100 mL in 1 BOTTLE, GLASS
CLINDAMYCIN PALMITATE HYDROCHLORIDE	clindamycin palmitate hydrochloride	FOR SOLUTION;ORAL	090902	ANDA	Bryant Ranch Prepack	63629-2523	63629-2523-1	1 BOTTLE, GLASS in 1 CARTON (63629-2523-1) / 100 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 75MG BASE/5ML
Approval Date:	Jul 7, 2010	TE:	AA	RLD:	No

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