Fosamax Plus D

Treats osteoporosis in postmenopausal women. NDA 21762, held by Organon LLC. Alendronate Sodium; Cholecalciferol.

As of Nov 14, 2026, NDA 21762 (Fosamax Plus D), held by Organon LLC, was first approved by FDA on Apr 7, 2005, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 7, 2005
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for: Treatment of osteoporosis in postmenopausal women Treatment to increase bone mass in men with osteoporosis Limitations of use: FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX PLUS D is indicated for the treatment of osteoporosis in postmenopausal women.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Apr 26, 2007	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 7, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Fosamax Plus DEQ 70MG BASE;2,800 IU · tablet;oral	Alendronate Sodium; Cholecalciferol	RxReference drug
Fosamax Plus DEQ 70MG BASE;5,600 IU · tablet;oral	Alendronate Sodium; Cholecalciferol	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Feb 3, 2026	Supplement 27Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 16, 2019	Supplement 22Labeling · Standard review	Approved	Label Letter
Nov 30, 2015	Supplement 21Labeling · Standard review	Approved	Label Letter
Jul 10, 2015	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 8, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 7, 2013	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 1, 2011	Supplement 15REMS	Approved	Letter
Jan 25, 2011	Supplement 13REMS	Approved	Letter Label
Mar 1, 2010	Supplement 10Labeling · Standard review	Approved	Letter Label
Mar 1, 2010	Supplement 9Labeling · Standard review	Approved	Letter Label
Mar 1, 2010	Supplement 5Labeling · Standard review	Approved	Letter Label
Oct 8, 2008	Supplement 6Labeling · Standard review	Approved	Label Letter
Apr 26, 2007	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 28, 2006	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 28, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 2, 2005	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 7, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21762
Drugs@FDA: Overview at FDA
Company: Organon

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