APPLICATION
ANDA091363
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-29
LATEST ACTION
2023-03-07
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 5MG BASE/100ML · INJECTABLE · INTRAVENOUS
Approval history
2023-03-07Labeling · Supplement 10 · standardAP
2017-09-18Labeling · Supplement 6 · standardAP
2015-09-02Labeling · Supplement 4 · standardAP
2015-04-09Labeling · Supplement 1 · 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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