Details for New Drug Application (NDA): 021575

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NDA 021575 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 021575

Tradename:	FOSAMAX
Applicant:	Merck
Ingredient:	alendronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 021575

Bone Density Conservation Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 17, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021575

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Sign Up	⤷ Sign Up
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Sign Up	⤷ Sign Up
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Sign Up	⤷ Sign Up
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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