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Johnson and Johnson

Last Updated: May 21, 2022

Details for New Drug Application (NDA): 020560

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NDA 020560 describes FOSAMAX, which is a drug marketed by Merck, Merck And Co Inc, and Organon, and is included in three NDAs. 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. Additional details are available on the alendronate sodium; cholecalciferol profile page.
Summary for 020560
Applicant:Merck And Co Inc
Ingredient:alendronate sodium
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020560

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 29, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Sep 29, 1995TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Apr 25, 1997TE:RLD:Yes

Expired US Patents for NDA 020560

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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