← FDA DRUG APPROVALS

FDA NDA · NDA021762

FOSAMAX PLUS D

alendronate sodium and cholecalciferol

Sponsor: ORGANON LLC

APPLICATION
NDA021762
TYPE
NDA
ORIGINAL APPROVAL
2005-04-07
LATEST ACTION
2026-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FOSAMAX PLUS D · ReferencePrescription
ALENDRONATE SODIUM EQ 70MG BASE, CHOLECALCIFEROL 2,800 IU · TABLET · ORAL
FOSAMAX PLUS D · ReferencePrescription
ALENDRONATE SODIUM EQ 70MG BASE, CHOLECALCIFEROL 5,600 IU · TABLET · ORAL

Approval history

2026-02-03Labeling · Supplement 27 · standard — Letter ↗AP
2019-08-16Labeling · Supplement 22 · standard — Letter ↗AP
2015-11-30Labeling · Supplement 21 · standard — Label ↗AP
2015-07-10Manufacturing (CMC) · Supplement 19 · standardAP
2015-04-08Labeling · Supplement 20 · standard — Letter ↗AP
2013-11-07Labeling · Supplement 18 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 17 · standard — Label ↗AP
2011-07-01REMS · Supplement 15 — Letter ↗AP
2011-01-25REMS · Supplement 13 — Label ↗AP
2010-03-01Labeling · Supplement 10 · standard — Label ↗AP
2010-03-01Labeling · Supplement 9 · standard — Letter ↗AP
2010-03-01Labeling · Supplement 5 · standard — Label ↗AP
2008-10-08Labeling · Supplement 6 · standard — Letter ↗AP
2007-04-26Efficacy · Supplement 4 · standard — Label ↗AP
2006-12-28Labeling · Supplement 2 · standard — Label ↗AP
2006-12-28Labeling · Supplement 3 · standard — Label ↗AP
2005-11-02Labeling · Supplement 1 · standard — Label ↗AP
2005-04-07Type 4 - New Combination · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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