Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078830

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NDA 078830 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 078830

Tradename:	SCOPOLAMINE
Applicant:	Padagis Us
Ingredient:	scopolamine
Patents:	0

Pharmacology for NDA: 078830

Mechanism of Action	Cholinergic Antagonists

Suppliers and Packaging for NDA: 078830

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	078830	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-580	45802-580-46	10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	078830	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-580	45802-580-62	24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	1MG/72HR
Approval Date:	Jan 30, 2015	TE:	AB	RLD:	No

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