APPLICATION
ANDA204222
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-16
LATEST ACTION
2026-02-03
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IBANDRONATE SODIUMPrescription
IBANDRONATE SODIUM EQ 3MG BASE/3ML · INJECTABLE · INTRAVENOUS
Approval history
2026-02-03Labeling · Supplement 5 · standardAP
2026-02-03Labeling · Supplement 4 · standardAP
2024-07-11Labeling · Supplement 3 · standardAP
2019-12-17Labeling · Supplement 1 · standardAP
2015-10-16UNKNOWN · 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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