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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 218384

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NDA 218384 describes SCOPOLAMINE, which is a drug marketed by Actavis Labs Ut Inc, Amneal, Mylan Technologies, Padagis Us, Rhodes Pharms, Riconpharma Llc, and Zydus Pharms, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the SCOPOLAMINE profile page.

The generic ingredient in SCOPOLAMINE is scopolamine. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the scopolamine profile page.

Summary for 218384

Tradename:	SCOPOLAMINE
Applicant:	Amneal
Ingredient:	scopolamine
Patents:	0

Pharmacology for NDA: 218384

Mechanism of Action	Cholinergic Antagonists

Suppliers and Packaging for NDA: 218384

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	218384	ANDA	Amneal Pharmaceuticals NY LLC	69238-1662	69238-1662-2	10 PATCH in 1 CARTON (69238-1662-2) / 3 d in 1 PATCH
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	218384	ANDA	Amneal Pharmaceuticals NY LLC	69238-1662	69238-1662-4	24 PATCH in 1 CARTON (69238-1662-4) / 3 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	1MG/72HR
Approval Date:	Jun 9, 2025	TE:	AB	RLD:	No

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