APPLICATION
ANDA204502
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-11
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 9 · standardAP
2022-02-22Labeling · Supplement 2 · standardAP
2016-03-11UNKNOWN · OriginalAP
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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