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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 two suppliers. There are ten 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 nineteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 205613

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;RECTALStrength2MG/ACTUATION
Approval Date:Oct 7, 2014TE:RLD:Yes
Patent:5,914,122Patent Expiration:Dec 19, 2015Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 7, 2017
Regulatory Exclusivity Use:NEW PRODUCT

Expired Orange Book Patents for NDA: 205613

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl
UCERIS
budesonide
AEROSOL, FOAM;RECTAL205613-001Oct 7, 20145,914,122► subscribe
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