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FDA NDA · NDA210566

LEXETTE

Sponsor: MAYNE PHARMA

APPLICATION
NDA210566
TYPE
NDA
ORIGINAL APPROVAL
2018-05-24
LATEST ACTION
2022-07-19
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

LEXETTE · ReferenceDiscontinued
HALOBETASOL PROPIONATE 0.05% · AEROSOL, FOAM · TOPICAL

Approval history

2022-07-19Labeling · Supplement 5 · standard — Letter ↗AP
2021-08-18Efficacy · Supplement 3 · standard — Letter ↗AP
2020-04-23Labeling · Supplement 2 · standard — Label ↗AP
2019-04-19Labeling · Supplement 1 · standard — Label ↗AP
2018-05-24Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Label ↗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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