Last Updated: September 24, 2026

Details for New Drug Application (NDA): 203063

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NDA 203063 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Extrovis, 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.

Summary for 203063

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 75MG BASE/5ML
Approval Date:	May 25, 2016	TE:		RLD:	No

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