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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 215329

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NDA 215329 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 215329

Tradename:	SCOPOLAMINE
Applicant:	Rhodes Pharms
Ingredient:	scopolamine
Patents:	0

Pharmacology for NDA: 215329

Mechanism of Action	Cholinergic Antagonists

Suppliers and Packaging for NDA: 215329

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	215329	ANDA	Rhodes Pharmaceuticals L.P.	42858-150	42858-150-14	10 POUCH in 1 BOX (42858-150-14) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
SCOPOLAMINE	scopolamine	SYSTEM;TRANSDERMAL	215329	ANDA	Rhodes Pharmaceuticals L.P.	42858-150	42858-150-40	4 POUCH in 1 BOX (42858-150-40) / 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:	May 6, 2024	TE:	AB	RLD:	No

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