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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021252

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NDA 021252 describes CANASA, which is a drug marketed by Allergan Sales 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-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 021252
Tradename:CANASA
Applicant:Allergan Sales Llc
Ingredient:mesalamine
Patents:2
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021252
Ingredient-typeAminosalicylic Acids
Medical Subject Heading (MeSH) Categories for 021252
Suppliers and Packaging for NDA: 021252
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANASA mesalamine SUPPOSITORY;RECTAL 021252 NDA Physicians Total Care, Inc. 54868-6147 E 54868-6147-0
CANASA mesalamine SUPPOSITORY;RECTAL 021252 NDA Allergan 58914-501 N 58914-501-33

Profile 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:ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength1GM
Approval Date:Nov 5, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 6, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 6, 2028Product Flag?YSubstance Flag?Delist Request?

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Cipla
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