Product Details for ANDA 075710
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
EQ 5MG BASE
Marketing Status: Discontinued
EQ 10MG BASE
Marketing Status: Discontinued
EQ 35MG BASE
Marketing Status: Discontinued
EQ 40MG BASE
Marketing Status: Discontinued
EQ 70MG BASE
Marketing Status: Discontinued
EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075710
Product Number: 001
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075710
Product Number: 001
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Discontinued
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:
Application Number: A075710
Product Number: 002
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
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:
Application Number: A075710
Product Number: 002
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 35MG BASE
Marketing Status: Discontinued
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:
Application Number: A075710
Product Number: 003
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
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:
Application Number: A075710
Product Number: 003
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 40MG BASE
Marketing Status: Discontinued
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075710
Product Number: 004
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075710
Product Number: 004
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 70MG BASE
Marketing Status: Discontinued
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:
Application Number: A075710
Product Number: 005
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
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:
Application Number: A075710
Product Number: 005
Approval Date: Feb 6, 2008
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information