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Generated: January 19, 2019

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Details for New Drug Application (NDA): 205613

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NDA 205613 describes UCERIS, which is a drug marketed by Valeant Pharms Intl and is included in two NDAs. It is available from three suppliers. There are thirteen 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 205613
Tradename:UCERIS
Applicant:Valeant Pharms Intl
Ingredient:budesonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205613
Medical Subject Heading (MeSH) Categories for 205613
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;RECTALStrength2MG/ACTUATION
Approval Date:Oct 7, 2014TE:RLD:Yes

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