← FDA DRUG APPROVALS

FDA NDA · NDA021060

PRIALT

ziconotide acetate

Sponsor: ESTEVE

APPLICATION
NDA021060
TYPE
NDA
ORIGINAL APPROVAL
2004-12-28
LATEST ACTION
2023-03-16
ROUTE
INTRATHECAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

PRIALT · ReferencePrescription
ZICONOTIDE ACETATE 500MCG/20ML (25MCG/ML) · INJECTABLE · INTRATHECAL
PRIALT · ReferencePrescription
ZICONOTIDE ACETATE 500MCG/5ML (100MCG/ML) · INJECTABLE · INTRATHECAL
PRIALT · ReferencePrescription
ZICONOTIDE ACETATE 100MCG/1ML (100MCG/ML) · INJECTABLE · INTRATHECAL
PRIALTDiscontinued
ZICONOTIDE ACETATE 200MCG/2ML (100MCG/ML) · INJECTABLE · INTRATHECAL

Approval history

2023-03-16Labeling · Supplement 12 · standard — Label ↗AP
2012-12-19Manufacturing (CMC) · Supplement 10 · priorityAP
2011-09-01Labeling · Supplement 6 · standard — Label ↗AP
2007-04-18Labeling · Supplement 3 · standard — Label ↗AP
2005-05-26Labeling · Supplement 1 · standard — Review ↗AP
2004-12-28Type 1 - New Molecular Entity · Original · priority — Label ↗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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