Last Updated: May 10, 2026

Details for New Drug Application (NDA): 214448

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NDA 214448 describes GLYCOPYRRONIUM TOSYLATE, which is a drug marketed by Padagis Us and is included in one NDA. Additional details are available on the GLYCOPYRRONIUM TOSYLATE profile page.

The generic ingredient in GLYCOPYRRONIUM TOSYLATE is glycopyrronium tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrronium tosylate profile page.

Summary for 214448

Tradename:	GLYCOPYRRONIUM TOSYLATE
Applicant:	Padagis Us
Ingredient:	glycopyrronium tosylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CLOTH;TOPICAL			Strength	EQ 2.4% BASE
Approval Date:	Apr 3, 2026	TE:	AB	RLD:	No

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