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sofpironium bromide

FDA Drug Profile — Sofdra

Drug Details

Generic Name
sofpironium bromide
Brand Names
Sofdra
Application Number
NDA217347
Sponsor
Botanix SB Inc.
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
SOFPIRONIUM BROMIDE

Indications and Usage

1 INDICATIONS AND USAGE SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).