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