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FDA NDA · NDA203231

ZOLEDRONIC ACID

Sponsor: INFORLIFE

APPLICATION
NDA203231
TYPE
NDA
ORIGINAL APPROVAL
2013-08-02
LATEST ACTION
2022-04-05
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZOLEDRONIC ACID · ReferencePrescription
ZOLEDRONIC ACID EQ 4MG BASE/100ML · INJECTABLE · INTRAVENOUS

Approval history

2022-04-05Labeling · Supplement 19 · standard — Label ↗AP
2020-10-27Labeling · Supplement 16 · standard — Label ↗AP
2020-10-27Labeling · Supplement 17 · standard — Label ↗AP
2020-10-27Labeling · Supplement 15 · standard — Letter ↗AP
2017-02-02Labeling · Supplement 13 · standard — Label ↗AP
2016-03-25Labeling · Supplement 11 · standard — Letter ↗AP
2015-10-08Labeling · Supplement 10 · standard — Label ↗AP
2015-08-31Manufacturing (CMC) · Supplement 8 · standardAP
2015-08-31Manufacturing (CMC) · Supplement 9 · standardAP
2014-12-10Labeling · Supplement 7 · standard — Label ↗AP
2014-12-10Labeling · Supplement 5 · standard — Label ↗AP
2014-12-10Labeling · Supplement 6 · standard — Letter ↗AP
2014-05-02Labeling · Supplement 2 · standard — Label ↗AP
2014-03-11Manufacturing (CMC) · Supplement 4 · standardAP
2014-02-07Manufacturing (CMC) · Supplement 1 · standardAP
2013-08-02Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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