APPLICATION
ANDA202828
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-23
LATEST ACTION
2025-08-15
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 5MG BASE/100ML · INJECTABLE · INTRAVENOUS
Approval history
2025-08-15Labeling · Supplement 17 · standardAP
2022-11-02Labeling · Supplement 10 · standardAP
2022-11-02Labeling · Supplement 13 · standardAP
2022-11-02Labeling · Supplement 11 · standardAP
2022-11-02Labeling · Supplement 9 · standardAP
2015-08-21Labeling · Supplement 7 · standardAP
2015-04-26Labeling · Supplement 3 · standardAP
2015-04-26Labeling · Supplement 4 · standardAP
2013-09-23UNKNOWN · 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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