Details for New Drug Application (NDA): 203513

NDA 203513 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 203513

Tradename:	CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:	Amneal Pharms
Ingredient:	clindamycin palmitate hydrochloride
Patents:	0

Pharmacology for NDA: 203513

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 203513

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE	clindamycin palmitate hydrochloride	FOR SOLUTION;ORAL	203513	ANDA	Amneal Pharmaceuticals of New York LLC	53746-468	53746-468-19	1 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE
CLINDAMYCIN PALMITATE HYDROCHLORIDE	clindamycin palmitate hydrochloride	FOR SOLUTION;ORAL	203513	ANDA	Amneal Pharmaceuticals LLC	65162-468	65162-468-19	1 BOTTLE in 1 CARTON (65162-468-19) / 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 75MG BASE/5ML
Approval Date:	Mar 13, 2014	TE:	AA	RLD:	No

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