APPLICATION
ANDA090557
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-18
LATEST ACTION
2022-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2022-10-14Labeling · Supplement 7 · standardAP
2015-09-21Labeling · Supplement 6 · standardAP
2015-09-21Labeling · Supplement 4 · standardAP
2012-12-10Labeling · Supplement 2 · standardAP
2012-04-30Labeling · Supplement 1AP
2010-02-18OriginalAP
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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