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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214448
Company: PADAGIS US

Products on ANDA 214448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYCOPYRRONIUM TOSYLATE	GLYCOPYRRONIUM TOSYLATE	EQ 2.4% BASE	CLOTH;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214448

GLYCOPYRRONIUM TOSYLATE

CLOTH;TOPICAL; EQ 2.4% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYCOPYRRONIUM TOSYLATE	GLYCOPYRRONIUM TOSYLATE	EQ 2.4% BASE	CLOTH;TOPICAL	Prescription	No	AB	214448	PADAGIS US
QBREXZA	GLYCOPYRRONIUM TOSYLATE	EQ 2.4% BASE	CLOTH;TOPICAL	Prescription	Yes	AB	210361	JOURNEY

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