Last Updated: November 8, 2026

Details for New Drug Application (NDA): 064159

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NDA 064159 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Fougera Pharms, Alembic, Amneal, Amvika, Aurobindo Pharma Ltd, Encube, 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, Chartwell Rx, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Ingenus Pharms Llc, Padagis Us, Pai Holdings Pharm, Ph Health, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Carnegie, 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-three NDAs. It is available from twenty-six suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are three 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 064159

Tradename:	CLINDAMYCIN PHOSPHATE
Applicant:	Fougera Pharms Inc
Ingredient:	clindamycin phosphate
Patents:	0

Pharmacology for NDA: 064159

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 064159

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	064159	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0201	0168-0201-30	1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLE
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	064159	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0201	0168-0201-60	1 BOTTLE in 1 CARTON (0168-0201-60) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	EQ 1% BASE
Approval Date:	Jun 5, 1997	TE:	AT	RLD:	No

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