APPLICATION
NDA019855
TYPE
NDA
ORIGINAL APPROVAL
1989-08-25
LATEST ACTION
2016-02-12
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
ELIMITE · ReferencePrescription
PERMETHRIN 5% · CREAM · TOPICAL
Approval history
2016-02-12Manufacturing (CMC) · Supplement 10 · standardAP
2001-12-27Manufacturing (CMC) · Supplement 7 · standardAP
2001-01-11Labeling · Supplement 5 · standardAP
2000-03-23Manufacturing (CMC) · Supplement 6 · standardAP
1995-01-30Manufacturing (CMC) · Supplement 4 · standardAP
1994-04-14Manufacturing (CMC) · Supplement 2 · standardAP
1993-05-05Efficacy · Supplement 1AP
1989-08-25Type 3 - New Dosage Form · Original · standardAP
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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