sofpironium bromide

FDA Drug Profile — Sofdra

sofpironium bromide is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Sofdra. Available dosage form: gel.

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 ).