Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208769

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NDA 208769 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 eleven suppliers. Additional details are available on the SCOPOLAMINE profile page.

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

Summary for 208769

Tradename:	SCOPOLAMINE
Applicant:	Actavis Labs Ut Inc
Ingredient:	scopolamine
Patents:	0

Pharmacology for NDA: 208769

Mechanism of Action	Cholinergic Antagonists

Suppliers and Packaging for NDA: 208769

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	208769	ANDA	Actavis Pharma, Inc.	0591-2258	0591-2258-04	4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	208769	ANDA	Actavis Pharma, Inc.	0591-2258	0591-2258-23	24 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	1MG/72HR
Approval Date:	Jan 10, 2022	TE:	AB	RLD:	No

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