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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203634
Company: SALIX

Summary Review

Products on NDA 203634

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UCERIS	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203634

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203634s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203634Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634_uceris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203634s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203634Orig1s007ltr.pdf
06/12/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/13/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203634s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203634Orig1s004ltr.pdf
07/06/2021	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
09/25/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/22/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203634

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203634s007lbl.pdf
10/13/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203634s004lbl.pdf
01/14/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203634s000lbl.pdf

Therapeutic Equivalents for NDA 203634

UCERIS

TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205457	ACTAVIS LABS FL INC
BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208851	MYLAN
UCERIS	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	203634	SALIX

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