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FDA NDA · NDA021575

FOSAMAX

Sponsor: MERCK

APPLICATION
NDA021575
TYPE
NDA
ORIGINAL APPROVAL
2003-09-17
LATEST ACTION
2015-11-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

FOSAMAX · ReferenceDiscontinued
ALENDRONATE SODIUM EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2015-11-30Labeling · Supplement 25 · standard — Label ↗AP
2015-04-08Labeling · Supplement 24 · standard — Label ↗AP
2013-12-23Labeling · Supplement 23 · standard — Label ↗AP
2013-04-19Labeling · Supplement 22 · standard — Letter ↗AP
2012-02-06Labeling · Supplement 17 · standard — Label ↗AP
2011-07-01REMS · Supplement 21 — Letter ↗AP
2011-01-25REMS · Supplement 20 — Letter ↗AP
2010-03-01Labeling · Supplement 18 · standard — Label ↗AP
2010-03-01Labeling · Supplement 16 · standard — Label ↗AP
2010-03-01Labeling · Supplement 12 · standard — Letter ↗AP
2008-10-08Labeling · Supplement 13 · standard — Label ↗AP
2006-12-28Labeling · Supplement 11 · standard — Label ↗AP
2006-12-28Labeling · Supplement 10 · standard — Letter ↗AP
2005-12-21Labeling · Supplement 7 · standard — Review ↗AP
2005-11-02Labeling · Supplement 9 · standard — Letter ↗AP
2004-12-01Labeling · Supplement 5 · standard — Letter ↗AP
2004-12-01Labeling · Supplement 6 · standard — Letter ↗AP
2004-04-27Labeling · Supplement 2 · standard — Letter ↗AP
2004-04-16Labeling · Supplement 4 · standard — Label ↗AP
2004-02-20Labeling · Supplement 3 · standard — Letter ↗AP
2003-09-17Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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