Details for New Drug Application (NDA): 050793

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NDA 050793 describes CLINDESSE, which is a drug marketed by Padagis Us and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CLINDESSE profile page.

The generic ingredient in CLINDESSE 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 050793

Tradename:	CLINDESSE
Applicant:	Padagis Us
Ingredient:	clindamycin phosphate
Patents:	1

Pharmacology for NDA: 050793

Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 050793

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793	NDA	Padagis Israel Pharmaceuticals Ltd	45802-042	45802-042-01	1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR
CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793	NDA	Padagis Israel Pharmaceuticals Ltd	45802-042	45802-042-02	1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	EQ 2% BASE
Approval Date:	Nov 30, 2004	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 2, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING BACTERIAL VAGINOSIS

Expired US Patents for NDA 050793

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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