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FDA NDA · NDA217347

SOFDRA

sofpironium bromide

Sponsor: BOTANIX SB

APPLICATION
NDA217347
TYPE
NDA
ORIGINAL APPROVAL
2024-06-18
LATEST ACTION
2024-06-18
ROUTE
TOPICAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Prescription

Products

SOFDRA · ReferencePrescription
SOFPIRONIUM BROMIDE EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) · GEL, METERED · TOPICAL

Approval history

2024-06-18Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
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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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