APPLICATION
ANDA078948
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-19
LATEST ACTION
2026-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBANDRONATE SODIUMPrescription
IBANDRONATE SODIUM EQ 150MG BASE · TABLET · ORAL
Approval history
2026-02-03Labeling · Supplement 14 · standardAP
2023-10-27Labeling · Supplement 9 · standardAP
2023-06-23Labeling · Supplement 8 · standardAP
2015-07-24Labeling · Supplement 5 · standardAP
2015-07-24Labeling · Supplement 6 · standardAP
2015-07-24Labeling · Supplement 2 · standardAP
2012-03-19OriginalAP
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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