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RISEDRONATE

 
 
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…

Actonel (risedronate sodium) Tablet, 35 mg, Procter & Gamble NDA 20-835/S8 & S9 5/17/02 5/23/02 Actonel (risedronate sodium) Tablet, 30 mg, Procter & Gamble NDA 20-835 3/27/98 4/10/02 4/10/02 Actonel (risedronate sodium) Tablet, 5 mg., Procter & Gamble NDA 20-835/S-001, 002, 003, & 004 Actonel (risedronate sodium) Tablet, Procter & Gamble Pharmaceuticals | Actonel (risedronate sodium) Tablets, Procter & Gamble Pharma, Labeling Revision | Risedronate Sodium Tablets, Teva Pharma, Tentative Approval | Actonel w/Calcium Tablets, Procter & Gamble, Approval | Actonel (risedronate sodium) Tablets, Procter & Gamble, Labeling Revision | Actonel (risedronate sodium) Tablets, Proctor & Gamble, Efficacy Sup w/Clinical Data | Actonel With Calcium Tablets, Proctor & Gamble, Efficacy Sup w/Clinical Data | Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets) Tablets, Procter & Gamble, Labeling Revision | Actonel (risedronate sodium) Tablets, Procter & Gamble, New or Modified Indication | Actonel (risedronate sodium) Tablets, Procter & Gamble Pharma, New Dosage Regimen | Actonel (risedronate sodium) Tablets, Procter & Gamble Pharma, Labeling Revision | Risedronate Sodium Tablets, Teva Pharma, Approval | Actonel (risedronate sodium) Tablets, Procter & Gamble, Labeling Revision | Actonel (risedronate sodium) Tablets, Procter & Gamble, New Dosage Regimen | Actonel (risedronate sodium) Tablets, P & G Pharmaceuticals, Inc., Efficacy Supp. w/Clinical Data | Actonel (risedronate sodium) Tablets, Procter & Gamble Pharmaceuticals, Inc., Labeling Revision | Actonel with Calcium (calcium carbonate and risedronate sodium) Tablets, Warner Chilcott, Labeling Revision |Actonel (risedronate sodium) Tablets, Warner Chilcott, Labeling Revision | Risedronate Sodium Tablets, Teva Pharmaceuticals, Tentative Approval | Actonel (risedronate sodium) Tablets, Warner Chilcott (US), LLC, Approval | Actonel with Calcium (calcium carbonate and risedronate sodium) Tablets, Warner Chilcott (US), LLC, Approval | Atelvia (risedronate sodium) Delayed-Release Tablets, Warner Chilcott (US), LLC, Approval

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

                                                                   

 

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