APPLICATION
ANDA202930
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-05
LATEST ACTION
2023-11-08
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 4MG BASE/5ML · INJECTABLE · INTRAVENOUS
Approval history
2023-11-08Manufacturing (CMC) · Supplement 13 · unknownAP
2016-07-13Labeling · Supplement 6 · standardAP
2015-10-19Labeling · Supplement 5 · standardAP
2015-05-27Labeling · Supplement 4 · standardAP
2015-01-02Labeling · Supplement 3 · standardAP
2015-01-02Labeling · Supplement 1 · standardAP
2015-01-02Labeling · Supplement 2 · standardAP
2013-08-05UNKNOWN · 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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