Details for New Drug Application (NDA): 050782

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NDA 050782 describes CLINDAGEL, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the CLINDAGEL profile page.

The generic ingredient in CLINDAGEL is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for 050782

Tradename:	CLINDAGEL
Applicant:	Bausch
Ingredient:	clindamycin phosphate
Patents:	0

Pharmacology for NDA: 050782

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 050782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782	NDA	Bausch Health US, LLC	16781-462	16781-462-06	6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE
CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782	NDA	Bausch Health US, LLC	16781-462	16781-462-75	1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	EQ 1% BASE
Approval Date:	Nov 27, 2000	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 050782

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782-001	Nov 27, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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