Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021532

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BENICAR HCT (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
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: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BENICAR HCT (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
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: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BENICAR HCT (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
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: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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