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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209914

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NDA 209914 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Fougera Pharms, Alembic, Amneal, Encube, Solaris Pharma Corp, 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, Endo Operations, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Padagis Us, Pai Holdings Pharm, 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 eighty-nine NDAs. It is available from twenty-one 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. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 209914

Tradename:	CLINDAMYCIN PHOSPHATE
Applicant:	Encube Ethicals
Ingredient:	clindamycin phosphate
Patents:	0

Pharmacology for NDA: 209914

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 209914

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	209914	ANDA	Encube Ethicals Private Limited	21922-002	21922-002-01	1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLE
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	209914	ANDA	Encube Ethicals Private Limited	21922-002	21922-002-21	1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	EQ 1% BASE
Approval Date:	Jan 28, 2019	TE:	AT	RLD:	No

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