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FDA NDA · NDA021385

ERTACZO

sertaconazole nitrate

Sponsor: LACER PHARMA

APPLICATION
NDA021385
TYPE
NDA
ORIGINAL APPROVAL
2003-12-10
LATEST ACTION
2020-12-17
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ERTACZO · ReferencePrescription
SERTACONAZOLE NITRATE 2% · CREAM · TOPICAL

Approval history

2020-12-17Labeling · Supplement 6 · standard — Label ↗AP
2014-01-22Labeling · Supplement 5 · standard — Letter ↗AP
2005-11-22Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2003-12-10Type 1 - New Molecular Entity · Original · standard — Review ↗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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