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FDA NDA · NDA019435

NIX

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APPLICATION
NDA019435
TYPE
NDA
ORIGINAL APPROVAL
1986-03-31
LATEST ACTION
1988-09-02
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

NIXDiscontinued
PERMETHRIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

1988-09-02Manufacturing (CMC) · Supplement 2 · priorityAP
1988-07-07Manufacturing (CMC) · Supplement 1 · priorityAP
1986-03-31Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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