FOSAMAX — FDA application NDA020560

Application NDA020560 · type NDA · FDA status: approved · original approval 1995-09-29

Listed sponsor: ORGANON · OGN company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	FOSAMAX	ALENDRONATE SODIUM	TABLET	ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
002	FOSAMAX	ALENDRONATE SODIUM	TABLET	ORAL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
003	FOSAMAX	ALENDRONATE SODIUM	TABLET	ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
004	FOSAMAX	ALENDRONATE SODIUM	TABLET	ORAL	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
005	FOSAMAX	ALENDRONATE SODIUM	TABLET	ORAL	EQ 70MG BASE	Prescription	AB	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

No Orange Book patent or exclusivity listings joined to this application.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.