Details for New Drug Application (NDA): 021056

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NDA 021056 describes TARGRETIN, which is a drug marketed by Valeant Luxembourg and Bausch and is included in two NDAs. It is available from two suppliers. Additional details are available on the TARGRETIN profile page.

The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bexarotene profile page.

Summary for 021056

Tradename:	TARGRETIN
Applicant:	Bausch
Ingredient:	bexarotene
Patents:	0

Pharmacology for NDA: 021056

Suppliers and Packaging for NDA: 021056

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TARGRETIN	bexarotene	GEL;TOPICAL	021056	NDA	Bausch Health US, LLC	0187-5525	0187-5525-60	1 TUBE in 1 CARTON (0187-5525-60) / 60 g in 1 TUBE
TARGRETIN	bexarotene	GEL;TOPICAL	021056	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-002	68682-002-60	1 TUBE in 1 CARTON (68682-002-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Jun 28, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021056

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	6,320,074	⤷ Subscribe
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	5,466,861	⤷ Subscribe
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	7,655,699	⤷ Subscribe
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	6,043,279	⤷ Subscribe
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	5,962,731	⤷ Subscribe
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	5,780,676	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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