Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205613
Company: SALIX

• Summary Review

Products on NDA 205613

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UCERIS	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205613

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2014	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2020	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205613s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205613Orig1s004ltr.pdf
11/13/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205613

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205613s004lbl.pdf
04/09/2020	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205613s004lbl.pdf
10/07/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf

Therapeutic Equivalents for NDA 205613

UCERIS

AEROSOL, FOAM;RECTAL; 2MG/ACTUATION
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUDESONIDE	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription	No	AB	215328	PADAGIS ISRAEL
UCERIS	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription	Yes	AB	205613	SALIX