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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022519
Company: HORIZON

Medication Guide

Summary Review

Products on NDA 022519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUEXIS	FAMOTIDINE; IBUPROFEN	26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 022519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2011	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022519s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519_duexis_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022519Orig1s013ltr.pdf
07/22/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022519s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022519Orig1s012ltr.pdf
06/07/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022519Orig1s011ltr.pdf
07/08/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/09/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022519s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022519Orig1s009ltr.pdf
03/04/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/28/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/31/2013	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
01/18/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/13/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022519

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf
04/28/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf
07/22/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022519s012lbl.pdf
06/07/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf
05/09/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022519s009lbl.pdf
04/23/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf

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