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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022442
Company: PERSION

Medication Guide

Summary Review

Products on NDA 022442

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REZIRA	HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2011	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022442s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022442s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442_rezira_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022442Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2018	SUPPL-10	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022439Orig1s010,022442Orig1s010,204307Orig1ss04ltr.pdf
01/13/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022442s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022439Orig1s009,022442Orig1s009,204307Orig1s003ltr.pdf

Labels for NDA 022442

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf
06/28/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf
01/13/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022442s009lbl.pdf
06/08/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022442s000lbl.pdf

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