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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204307
Company: PERSION

Medication Guide

Summary Review

Products on NDA 204307

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VITUZ	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE	4MG/5ML;5MG/5ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204307

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2013	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/2013/204307s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204307Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204307_vituz_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204307Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2018	SUPPL-4	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022439Orig1s010,022442Orig1s010,204307Orig1ss04ltr.pdf
01/13/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204307s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022439Orig1s009,022442Orig1s009,204307Orig1s003ltr.pdf

Labels for NDA 204307

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf
06/28/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf
01/13/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204307s003lbl.pdf
02/20/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204307s000lbl.pdf

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