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Details for New Drug Application (NDA): 021252

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NDA 021252 describes CANASA, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CANASA profile page.

The generic ingredient in CANASA is mesalamine. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 021252

Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021252

Ingredient-typeAminosalicylic Acids

Suppliers and Packaging for NDA: 021252

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPPOSITORY;RECTAL 021252 NDA Physicians Total Care, Inc. 54868-6147 54868-6147-0 30 SUPPOSITORY in 1 BOX (54868-6147-0)
SUPPOSITORY;RECTAL 021252 NDA Allergan 58914-501 58914-501-33 3 SUPPOSITORY in 1 BOX (58914-501-33)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength500MG
Approval Date:Jan 5, 2001TE:RLD:No
Regulatory Exclusivity Expiration:Sep 2, 2019
Regulatory Exclusivity Use:

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength1GM
Approval Date:Nov 5, 2004TE:ABRLD:Yes
Patent:8,217,083Patent Expiration:Jun 6, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,436,051Patent Expiration:Jun 6, 2028Product Flag?YSubstance Flag?Delist Request?

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