Product Details for ANDA 203533
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
5MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
35MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203533
Product Number: 001
Approval Date: Dec 9, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203533
Product Number: 001
Approval Date: Dec 9, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203533
Product Number: 002
Approval Date: Dec 9, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203533
Product Number: 002
Approval Date: Dec 9, 2015
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
35MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 35MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203533
Product Number: 003
Approval Date: Nov 29, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 35MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203533
Product Number: 003
Approval Date: Nov 29, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information