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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

Tradename:	FOSAMAX
Applicant:	Merck And Co Inc
Ingredient:	alendronate sodium
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020560

Bone Density Conservation Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Sep 29, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Sep 29, 1995	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Apr 25, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020560

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997	See Plans and Pricing	See Plans and Pricing
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	See Plans and Pricing	See Plans and Pricing
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995	See Plans and Pricing	See Plans and Pricing
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	See Plans and Pricing	See Plans and Pricing
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000	See Plans and Pricing	See Plans and Pricing
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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