Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021762

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FOSAMAX PLUS D (ALENDRONATE SODIUM; CHOLECALCIFEROL)
EQ 70MG BASE;2,800 IU Marketing Status: Prescription

Active Ingredient: ALENDRONATE SODIUM; CHOLECALCIFEROL
Proprietary Name: FOSAMAX PLUS D
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 70MG BASE;2,800 IU
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021762
Product Number: 001
Approval Date: Apr 7, 2005
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FOSAMAX PLUS D (ALENDRONATE SODIUM; CHOLECALCIFEROL)
EQ 70MG BASE;5,600 IU Marketing Status: Prescription

Active Ingredient: ALENDRONATE SODIUM; CHOLECALCIFEROL
Proprietary Name: FOSAMAX PLUS D
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 70MG BASE;5,600 IU
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021762
Product Number: 002
Approval Date: Apr 26, 2007
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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