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MESALAMINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Canasa (mesalamine) Suppositories, Axcan Scandipharm NDA 21-252/S2 10/14/03 10/17/03 | Canasa (mesalamine) Suppositories, Axcan Scandipharm NDA 21-252 | Pentasa (Mesalamine) Capsules Roberts NDA 20-049/S006 MESALAMINE Capsule, Extended Release; 250MG PENTASA SHIRE | 019618 MESALAMINE Enema; Rectal 4GM/60ML ROWASA SOLVAY | 021252 MESALAMINE Suppository; Rectal 500MG CANASA AXCAN SCANDIPHARM | 019651 MESALAMINE Tablet, Delayed Release; 400MG ASACOL PROCTER AND GAMBLE Pentasa (meslamine) Controlled Release Capsules, Shire Pharmaceutical, Control Supplement | Mesalamine Rectal Suspension, Clay-Park Labs, Approval | CANASA (mesalamine) Suppository, Axcan Scandipharm, Labeling Revision | Canasa (Mesalamine, USP) Rectal Suppositories, Axcan Scandipharm, New Dosage Regimen | ROWASA (mesalamine) Rectal Suspension Enema, Solvay Pharma, Labeling Revision | Canasa (mesalamine) Suppository, Axcan Scandipharm, Labeling Revision | Pentasa (mesalamine) Controlled-Release Capsules, Shire Dev., Labeling Revision | Lialda (mesalamine) Delayed Release Tablets, Shire Development, Approval | Asacol (mesalamine) Delayed Release Tablets, Procter & Gamble Pharma, Labeling Revision | Mesalamine Rectal Suspension, Perrigo Co., Control Supplement | Pentasa (mesalamine) Controlled-Release Capsules, Shire Dev., Labeling Revision | CANASA (mesalamine) Suppository, Axcan Scandipharma Inc., Package Change | Tradename To Be Determined (mesalamine) Delayed-Release Tablets, Procter & Gamble Pharmaceuticals, Approval | Rowasa (mesalamine) Enema, Alaven Pharmaceutical, LLC, Formulation Revision | Apriso (mesalamine) Extended-Release Capsules, Salix Pharmaceuticals, Inc., Approval | Asacol HD (mesalamine) Delayed-Release Tablets, Procter & Gamble Pharmaceuticals, Inc., Labeling Revision | Lialda (mesalamine) Delayed-Release Tablets, Shire Development Inc., Labeling Revision | Lialda (mesalamine) Delayed-Release Tablet, Shire Development Inc., Labeling Revision | Lialda (mesalamine) Delayed-Release Tablets, Shire Development, Inc., Efficacy Supplement with Clinical Data to Support

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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