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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 four 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. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the balsalazide disodium profile page.

Summary for NDA: 020610

Valeant Pharms Intl
balsalazide disodium
Therapeutic Class:Inflammatory Bowel Disease Agents

Pharmacology for NDA: 020610

Ingredient-typeAminosalicylic Acids

Suppliers and Packaging for NDA: 020610

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
balsalazide disodium
CAPSULE;ORAL 020610 NDA Cardinal Health 55154-6775 55154-6775-0 10 POUCH in 1 BAG (55154-6775-0) > 1 CAPSULE in 1 POUCH
balsalazide disodium
CAPSULE;ORAL 020610 NDA Cardinal Health 55154-6775 55154-6775-4 280 POUCH in 1 CARTON (55154-6775-4) > 1 CAPSULE in 1 POUCH (55154-6775-6)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength750MG
Approval Date:Jul 18, 2000TE:ABRLD:Yes
Patent:7,452,872*PEDPatent Expiration:Feb 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:7,625,884*PEDPatent Expiration:Feb 24, 2027Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020610

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl
balsalazide disodium
CAPSULE;ORAL020610-001Jul 18, 20004,412,992*PED► subscribe
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