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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020560

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FOSAMAX (ALENDRONATE SODIUM)
EQ 70MG BASE
Marketing Status: Prescription
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: FOSAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 70MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020560
Product Number: 005
Approval Date: Oct 20, 2000
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
FOSAMAX (ALENDRONATE SODIUM)
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: FOSAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020560
Product Number: 003
Approval Date: Apr 25, 1997
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
FOSAMAX (ALENDRONATE SODIUM)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: FOSAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020560
Product Number: 001
Approval Date: Sep 29, 1995
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
FOSAMAX (ALENDRONATE SODIUM)
EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: FOSAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020560
Product Number: 004
Approval Date: Oct 20, 2000
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
FOSAMAX (ALENDRONATE SODIUM)
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: FOSAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020560
Product Number: 002
Approval Date: Sep 29, 1995
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
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