APPLICATION
ANDA201783
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-12
LATEST ACTION
2024-06-06
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 4MG BASE/5ML · INJECTABLE · INTRAVENOUS
Approval history
2024-06-06Labeling · Supplement 24 · standardAP
2016-07-14Labeling · Supplement 11 · standardAP
2015-11-09Labeling · Supplement 9 · standardAP
2015-03-31Labeling · Supplement 7 · standardAP
2015-03-31Labeling · Supplement 3 · standardAP
2015-03-31Labeling · Supplement 4 · standardAP
2013-03-12Not Applicable · 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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