Fosamax

NDA 21575, held by Merck. Alendronate Sodium.

As of Nov 14, 2026, NDA 21575 (Fosamax), held by Merck, was first approved by FDA on Sep 17, 2003, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 17, 2003
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Sep 17, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
FosamaxEQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Alendronate Sodium	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Nov 30, 2015	Supplement 25Labeling · Standard review	Approved	Label Letter
Apr 8, 2015	Supplement 24Labeling · Standard review	Approved	Medication Guide Letter Label
Dec 23, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 6, 2012	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 1, 2011	Supplement 21REMS	Approved	Letter
Jan 25, 2011	Supplement 20REMS	Approved	Letter Label
Mar 1, 2010	Supplement 12Labeling · Standard review	Approved	Letter Label
Mar 1, 2010	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 1, 2010	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 8, 2008	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 28, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 28, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 21, 2005	Supplement 7Labeling · Standard review	Approved	Letter Review
Nov 2, 2005	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 1, 2004	Supplement 5Labeling · Standard review	Approved	Letter Label
Dec 1, 2004	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 27, 2004	Supplement 2Labeling · Standard review	Approved	Letter
Apr 16, 2004	Supplement 4Labeling · Standard review	Approved	Review Label Letter
Feb 20, 2004	Supplement 3Labeling · Standard review	Approved	Review Label Letter
Sep 17, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21575
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters