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SOFDRA

NDA · New Drug Application · Sponsor: BOTANIX SB · Approved 2024-06-18

Drug application

FDA Application #

NDA217347

Application type

New Drug Application

Brand name

SOFDRA

Generic name

SOFPIRONIUM BROMIDE

Active ingredients

SOFPIRONIUM BROMIDE

Dosage form

GEL, METERED

Route

TOPICAL

Marketing status

Prescription

Sponsor

BOTANIX SB

Manufacturer

Botanix SB Inc.

First approval

2024-06-18

Source

Authoritative

Drugs@FDA application overview

Machine

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