Product Details for ANDA 091351
TELMISARTAN AND HYDROCHLOROTHIAZIDE (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: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091351
Product Number: 001
Approval Date: Aug 7, 2014
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
TELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; TELMISARTAN)
Proprietary Name: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091351
Product Number: 001
Approval Date: Aug 7, 2014
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
12.5MG;80MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; TELMISARTAN
Proprietary Name: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091351
Product Number: 002
Approval Date: Aug 7, 2014
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
TELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; TELMISARTAN)
Proprietary Name: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091351
Product Number: 002
Approval Date: Aug 7, 2014
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
25MG;80MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; TELMISARTAN
Proprietary Name: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091351
Product Number: 003
Approval Date: Aug 7, 2014
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: TELMISARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091351
Product Number: 003
Approval Date: Aug 7, 2014
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Prescription
Patent and Exclusivity Information