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Details for New Drug Application (NDA): 021575

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NDA 021575 describes FOSAMAX, which is a drug marketed by Merck And Co Inc and Merck and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSAMAX profile page.

The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Summary for NDA: 021575

alendronate sodium
Therapeutic Class:Metabolic Bone Disease Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrengthEQ 70MG BASE/75ML
Approval Date:Sep 17, 2003TE:RLD:No
Patent:5,994,329*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,015,801*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,225,294*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021575

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 20034,621,077*PED<disabled>
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 20035,462,932*PED<disabled>
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