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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205613

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NDA 205613 describes UCERIS, which is a drug marketed by Salix and is included in two NDAs. It is available from three suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the UCERIS profile page.

The generic ingredient in UCERIS is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 205613

Tradename:	UCERIS
Applicant:	Salix
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 205613

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 205613

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 205613

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613	NDA	Salix Pharmaceuticals, Inc.	65649-651	65649-651-03	2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)
UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613	NDA	Oceanside Pharmaceuticals	68682-658	68682-658-03	2 CANISTER in 1 CARTON (68682-658-03) / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, FOAM;RECTAL			Strength	2MG/ACTUATION
Approval Date:	Oct 7, 2014	TE:	AB	RLD:	Yes

Expired US Patents for NDA 205613

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014	5,914,122	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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