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Generated: November 13, 2018

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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 two suppliers. 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. Eight 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
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 AUTHORIZED GENERIC Salix Pharmaceuticals, Inc 65649-101 65649-101-02 280 CAPSULE in 1 BOTTLE (65649-101-02)
COLAZAL balsalazide disodium CAPSULE;ORAL 020610 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-750 68682-750-02 280 CAPSULE in 1 BOTTLE (68682-750-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength750MG
Approval Date:Jul 18, 2000TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Feb 24, 2027Product Flag?Substance Flag?Delist Request?Y

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