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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022205
Company: VALEANT PHARMS INTL

Summary Review

Products on NDA 022205

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GIAZO	BALSALAZIDE DISODIUM	1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022205

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022205s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022205s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205_giazo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022205s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022205Orig1s005ltr.pdf
10/01/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022205Orig1s004ltr.pdf
01/07/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022205Orig1s003ltr.pdf
01/05/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/16/2013	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022205Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022205Orig1s001ltr.pdf

Labels for NDA 022205

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022205s005lbl.pdf
10/01/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s004lbl.pdf
01/07/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s003lbl.pdf
12/16/2013	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022205Orig1s001lbl.pdf
02/03/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022205s000lbl.pdf

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