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FDA NDA · NDA206255

SOOLANTRA

ivermectin

Sponsor: GALDERMA LABS LP

APPLICATION
NDA206255
TYPE
NDA
ORIGINAL APPROVAL
2014-12-19
LATEST ACTION
2022-10-14
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

SOOLANTRA · ReferencePrescription
IVERMECTIN 1% · CREAM · TOPICAL

Approval history

2022-10-14Labeling · Supplement 9 · standard — Letter ↗AP
2022-10-14Labeling · Supplement 5 · standard — Letter ↗AP
2018-04-19Labeling · Supplement 4 · standard — Label ↗AP
2014-12-19Type 3 - New Dosage Form · Original · standard — Label ↗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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