Product Details for NDA 021162
MICARDIS HCT (HYDROCHLOROTHIAZIDE; TELMISARTAN)
12.5MG;40MG
Marketing Status: Prescription
12.5MG;80MG
Marketing Status: Prescription
25MG;80MG
Marketing Status: Prescription
12.5MG;40MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; TELMISARTAN
Proprietary Name: MICARDIS HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021162
Product Number: 001
Approval Date: Nov 17, 2000
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Prescription
Patent and Exclusivity Information
MICARDIS HCT (HYDROCHLOROTHIAZIDE; TELMISARTAN)
Proprietary Name: MICARDIS HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021162
Product Number: 001
Approval Date: Nov 17, 2000
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Prescription
Patent and Exclusivity Information
12.5MG;80MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; TELMISARTAN
Proprietary Name: MICARDIS HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021162
Product Number: 002
Approval Date: Nov 17, 2000
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Prescription
Patent and Exclusivity Information
MICARDIS HCT (HYDROCHLOROTHIAZIDE; TELMISARTAN)
Proprietary Name: MICARDIS HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021162
Product Number: 002
Approval Date: Nov 17, 2000
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Prescription
Patent and Exclusivity Information
25MG;80MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; TELMISARTAN
Proprietary Name: MICARDIS HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021162
Product Number: 003
Approval Date: Apr 19, 2004
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: MICARDIS HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021162
Product Number: 003
Approval Date: Apr 19, 2004
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Prescription
Patent and Exclusivity Information