APPLICATION
ANDA075871
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-22
LATEST ACTION
2016-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 40MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
Approval history
2016-02-25Labeling · Supplement 3 · standardAP
2016-02-25Labeling · Supplement 2 · standardAP
2015-01-20Labeling · Supplement 1AP
2009-04-22OriginalAP
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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