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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 021351

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NDA 021351 describes OXYTROL, which is a drug marketed by Allergan and Abbvie and is included in two NDAs. It is available from one supplier. Additional details are available on the OXYTROL profile page.

The generic ingredient in OXYTROL is oxybutynin. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.

Summary for 021351

Tradename:	OXYTROL
Applicant:	Allergan
Ingredient:	oxybutynin
Patents:	0

Pharmacology for NDA: 021351

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 021351

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351	NDA	Allergan, Inc.	0023-6153	0023-6153-08	8 POUCH in 1 BOX (0023-6153-08) / 1 PATCH in 1 POUCH / 4 d in 1 PATCH

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	3.9MG/24HR
Approval Date:	Feb 26, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021351

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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