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

Pharmacology for NDA: 020560

Medical Subject Heading (MeSH) Categories for 020560

Bone Density Conservation Agents

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:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
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
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	6,194,004*PED	⤷ Get Started Free
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	6,015,801	⤷ Get Started Free
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997	6,008,207*PED	⤷ Get Started Free
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000	5,358,941*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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