APPLICATION
ANDA204217
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-18
LATEST ACTION
2023-03-08
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ZOLEDRONIC ACIDPrescription
ZOLEDRONIC ACID EQ 5MG BASE/100ML · INJECTABLE · INTRAVENOUS
Approval history
2023-03-08Labeling · Supplement 3 · standardAP
2023-03-08Labeling · Supplement 1 · standardAP
2016-08-18UNKNOWN · 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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