APPLICATION
ANDA206058
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-05
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 7 · standardAP
2025-07-25Labeling · Supplement 6 · standardAP
2019-12-12Labeling · Supplement 1 · standardAP
2016-02-05UNKNOWN · Original · standardAP
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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