Product Details for NDA 021532
BENICAR HCT (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
12.5MG;20MG
Marketing Status: Prescription
12.5MG;40MG
Marketing Status: Prescription
25MG;40MG
Marketing Status: Prescription
12.5MG;20MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: BENICAR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021532
Product Number: 002
Approval Date: Jun 5, 2003
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
BENICAR HCT (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
Proprietary Name: BENICAR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021532
Product Number: 002
Approval Date: Jun 5, 2003
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
12.5MG;40MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: BENICAR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021532
Product Number: 003
Approval Date: Jun 5, 2003
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
BENICAR HCT (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
Proprietary Name: BENICAR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021532
Product Number: 003
Approval Date: Jun 5, 2003
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG;40MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: BENICAR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021532
Product Number: 005
Approval Date: Jun 5, 2003
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: BENICAR HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021532
Product Number: 005
Approval Date: Jun 5, 2003
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information