Details for New Drug Application (NDA): 050802

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NDA 050802 describes ZIANA, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the ZIANA profile page.

The generic ingredient in ZIANA 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 050802

Tradename:	ZIANA
Applicant:	Bausch
Ingredient:	clindamycin phosphate; tretinoin
Patents:	0

Pharmacology for NDA: 050802

Physiological Effect	Decreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 050802

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-300	68682-300-30	1 TUBE in 1 CARTON (68682-300-30) / 30 g in 1 TUBE
ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-300	68682-300-60	1 TUBE in 1 CARTON (68682-300-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1.2%;0.025%
Approval Date:	Nov 7, 2006	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 050802

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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