Product Details for ANDA 090124
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
EQ 10MG BASE
Marketing Status: Prescription
EQ 35MG BASE
Marketing Status: Prescription
EQ 70MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090124
Product Number: 001
Approval Date: Aug 4, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090124
Product Number: 001
Approval Date: Aug 4, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 35MG BASE
Marketing Status: Prescription
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 35MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090124
Product Number: 002
Approval Date: Aug 4, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 35MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090124
Product Number: 002
Approval Date: Aug 4, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 70MG BASE
Marketing Status: Prescription
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 70MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090124
Product Number: 003
Approval Date: Aug 4, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 70MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090124
Product Number: 003
Approval Date: Aug 4, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information