APPLICATION
ANDA075710
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-06
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 40MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
Approval history
2026-04-23Labeling · Supplement 25 · standardAP
2023-01-31Labeling · Supplement 22 · standardAP
2016-03-29Labeling · Supplement 18 · standardAP
2015-07-16Labeling · Supplement 17 · standardAP
2015-07-16Labeling · Supplement 12 · standardAP
2013-07-15Manufacturing (CMC) · Supplement 9AP
2012-05-22Labeling · Supplement 10 · standardAP
2011-04-01Labeling · Supplement 8AP
2010-04-22Labeling · Supplement 4AP
2009-10-20Labeling · Supplement 3AP
2009-01-23Labeling · Supplement 1AP
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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