Details for New Drug Application (NDA): 020610

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NDA 020610 describes COLAZAL, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the COLAZAL profile page.

The generic ingredient in COLAZAL is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

Summary for 020610

Tradename:	COLAZAL
Applicant:	Valeant Pharms Intl
Ingredient:	balsalazide disodium
Patents:	2

Pharmacology for NDA: 020610

Suppliers and Packaging for NDA: 020610

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610	NDA	Salix Pharmaceuticals, Inc	65649-101	65649-101-02	280 CAPSULE in 1 BOTTLE (65649-101-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	750MG
Approval Date:	Jul 18, 2000	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 24, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Feb 24, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020610

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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