APPLICATION
ANDA090258
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-24
LATEST ACTION
2017-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2017-04-18Manufacturing (CMC) · Supplement 10AP
2013-03-29Manufacturing (CMC) · Supplement 2AP
2012-09-26Labeling · Supplement 9 · standardAP
2012-05-16Labeling · Supplement 4AP
2009-09-24OriginalAP
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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