APPLICATION
ANDA202923
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-04
LATEST ACTION
2023-05-19
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 4MG BASE/5ML · INJECTABLE · INTRAVENOUS
Approval history
2023-05-19Labeling · Supplement 14 · standardAP
2023-05-19Labeling · Supplement 7 · standardAP
2016-12-01Labeling · Supplement 6 · standardAP
2015-09-11Labeling · Supplement 5 · standardAP
2015-09-11Labeling · Supplement 3 · standardAP
2014-09-04UNKNOWN · 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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