APPLICATION
ANDA202671
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-02
LATEST ACTION
2026-02-03
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
IBANDRONATE SODIUMDiscontinued
IBANDRONATE SODIUM EQ 3MG BASE/3ML · INJECTABLE · INTRAVENOUS
Approval history
2026-02-03Labeling · Supplement 9 · standardAP
2025-08-06Labeling · Supplement 7 · standardAP
2018-04-06Labeling · Supplement 4 · standardAP
2018-04-06Manufacturing (CMC) · Supplement 2AP
2015-09-02Labeling · Supplement 1 · standardAP
2014-09-02UNKNOWN · 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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