Details for New Drug Application (NDA): 202409

NDA 202409 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. Ten suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.

Summary for 202409

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

Pharmacology for NDA: 202409

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 202409

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE	clindamycin palmitate hydrochloride	FOR SOLUTION;ORAL	202409	ANDA	NorthStar Rx LLC	16714-483	16714-483-01	1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE
CLINDAMYCIN PALMITATE HYDROCHLORIDE	clindamycin palmitate hydrochloride	FOR SOLUTION;ORAL	202409	ANDA	NorthStar Rx LLC	16714-483	16714-483-02	1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 75MG BASE/5ML
Approval Date:	Apr 30, 2013	TE:	AA	RLD:	No

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