Product Details for ANDA 203813
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
4MG
Marketing Status: Prescription
8MG
Marketing Status: Prescription
16MG
Marketing Status: Prescription
32MG
Marketing Status: Prescription
4MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 001
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 001
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
8MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 002
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 002
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
16MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 003
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 003
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
32MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 004
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203813
Product Number: 004
Approval Date: Dec 5, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information