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OLMESARTAN

 
 
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…

Benicar HCT Tablets, Sankyo Pharma, NDA 21-532 6/5/03 6/9/03 6/9/03 9/10/03 Benicar (olmesartan medoxomil) Tablets, 5, 20, and 40 mg, Sankyo Pharma, NDA 21-286/S2 2/12/03 2/25/03 Benicar (olmesartan medoxomil) Tablets, 5, 20, and 40 mg, Sankyo Pharma, NDA 21-286/S1 10/25/02 10/28/02 Benicar (olmesartan medoxomil) Tablets, 5, 20, and 40 mg, Sankyo Pharma, NDA 21-286 | Benicar (olmesartan medoxomil) Tablets, Sankyo Pharma Inc., Labeling Revision | Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets, Sankyo Pharma Inc., Labeling Revision | Benicar (olmesartan medoxomil) Tablets, Sankyo Pharma, Inc., Labeling Revision | Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) Tablets, Sankyo Pharma, Inc., Labeling Revision | AZOR (amlodipine and olmesartan medoxomil) Tablets, Daiichi Sankyo, Approval | Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision | Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets, Daichi Sankyo, Labeling Revision | Olmesartan Medoxomil Tablets, Mylan Pharma, Tentative Approval | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo Pharma Development, New or Modified Indication | Olmesartan Medoxomil Tablets, Sandoz Inc., Tentative Approval | Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Efficacy Supplement | Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Approval | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Benicar HCT (olmesartan medoxomil and hydrochlorothiazide) Tablets, Daiichi Sankyo, Labeling Revision | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Labeling Revision | Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision | Tribenzor, amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil, Tablet; Oral, Daiichi Sankyo, Labeling Revision

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

                                                                   

 

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