Product Details for ANDA 090886
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
5MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
35MG
Marketing Status: Prescription
75MG
Marketing Status: Prescription
150MG
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: A090886
Product Number: 001
Approval Date: Nov 30, 2015
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES 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: A090886
Product Number: 001
Approval Date: Nov 30, 2015
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES 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: A090886
Product Number: 002
Approval Date: Nov 30, 2015
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES 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: A090886
Product Number: 002
Approval Date: Nov 30, 2015
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES 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: A090886
Product Number: 003
Approval Date: Nov 30, 2015
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
RISEDRONATE SODIUM (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: A090886
Product Number: 003
Approval Date: Nov 30, 2015
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
75MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090886
Product Number: 004
Approval Date: Jun 10, 2014
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090886
Product Number: 004
Approval Date: Jun 10, 2014
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
150MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090886
Product Number: 005
Approval Date: Jun 10, 2014
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090886
Product Number: 005
Approval Date: Jun 10, 2014
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information