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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020560


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NDA 020560 describes FOSAMAX, which is a drug marketed by Merck, Organon, and Organon Llc, and is included in three NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.
Summary for 020560
Tradename:FOSAMAX
Applicant:Organon
Ingredient:alendronate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020560
Medical Subject Heading (MeSH) Categories for 020560
Suppliers and Packaging for NDA: 020560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSAMAX alendronate sodium TABLET;ORAL 020560 NDA Organon LLC 78206-135 78206-135-01 4 TABLET in 1 BLISTER PACK (78206-135-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 29, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 29, 1995TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 25, 1997TE:RLD:Yes

Expired US Patents for NDA 020560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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