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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 203634


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NDA 203634 describes UCERIS, which is a drug marketed by Salix and is included in two NDAs. It is available from four 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 203634
Tradename:UCERIS
Applicant:Salix
Ingredient:budesonide
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 203634
Medical Subject Heading (MeSH) Categories for 203634
Suppliers and Packaging for NDA: 203634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-9093 63629-9093-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9093-1)
UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634 NDA Santarus Inc. 68012-309 68012-309-01 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength9MG
Approval Date:Jan 14, 2013TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 7, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Sep 7, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Sep 7, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 203634

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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