APPLICATION
ANDA202837
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-05
LATEST ACTION
2022-11-01
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ZOLEDRONIC ACIDDiscontinued
ZOLEDRONIC ACID EQ 5MG BASE/100ML · INJECTABLE · INTRAVENOUS
Approval history
2022-11-01Labeling · Supplement 7 · standardAP
2022-11-01Labeling · Supplement 6 · standardAP
2017-03-01Labeling · Supplement 4 · standardAP
2015-09-22Labeling · Supplement 3 · standardAP
2014-11-20Labeling · Supplement 2 · standardAP
2013-04-05UNKNOWN · 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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