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FDA NDA · NDA022483

ZYCLARA

imiquimod

Sponsor: BAUSCH

APPLICATION
NDA022483
TYPE
NDA
ORIGINAL APPROVAL
2010-03-25
LATEST ACTION
2024-09-16
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ZYCLARA · ReferencePrescription
IMIQUIMOD 3.75% · CREAM · TOPICAL
ZYCLARA · ReferencePrescription
IMIQUIMOD 2.5% · CREAM · TOPICAL

Approval history

2024-09-16Labeling · Supplement 11 · standard — Letter ↗AP
2014-11-24Manufacturing (CMC) · Supplement 7 · standardAP
2012-02-14Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2011-09-29Labeling · Supplement 2 · unknown — Label ↗AP
2011-07-15Efficacy · Supplement 3 · standard — Letter ↗AP
2011-03-24Efficacy · Supplement 1 · standard — Letter ↗AP
2010-03-25Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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