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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 065513

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NDA 065513 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Fougera Pharms, Alembic, Amneal, Encube, Quagen, Solaris Pharma Corp, Sun Pharma Canada, Zydus Lifesciences, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Boca Pharma Llc, Carnegie, Chartwell Rx, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Padagis Us, Pai Holdings Pharm, Ph Health, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Epic Pharma Llc, Actavis Labs Ut Inc, Glenmark Speclt, Mylan Pharms Inc, Zydus Pharms, Actavis Mid Atlantic, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, and Baxter Hlthcare, and is included in ninety NDAs. It is available from twenty-five suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 065513

Tradename:	CLINDAMYCIN PHOSPHATE
Applicant:	Epic Pharma Llc
Ingredient:	clindamycin phosphate
Patents:	0

Pharmacology for NDA: 065513

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 065513

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SWAB;TOPICAL	065513	ANDA	i3 Pharmaceuticals, LLC	72319-696	72319-696-60	60 APPLICATOR in 1 JAR (72319-696-60) / 1 mL in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SWAB;TOPICAL			Strength	EQ 1% BASE
Approval Date:	Jun 17, 2010	TE:	AT	RLD:	No

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