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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203753

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NDA 203753 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 203753

Tradename:	SCOPOLAMINE
Applicant:	Mylan Technologies
Ingredient:	scopolamine
Patents:	0

Pharmacology for NDA: 203753

Mechanism of Action	Cholinergic Antagonists

Suppliers and Packaging for NDA: 203753

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	203753	ANDA	Mylan Pharmaceuticals Inc.	0378-6470	0378-6470-44	24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	203753	ANDA	Mylan Pharmaceuticals Inc.	0378-6470	0378-6470-97	10 POUCH in 1 CARTON (0378-6470-97) / 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:	Jun 19, 2019	TE:	AB	RLD:	No

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