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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022279
Company: CHARTWELL RX

Medication Guide

Summary Review

Products on NDA 022279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYCOFENIX	GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG/5ML;2.5MG/5ML;30MG/5ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2015	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022279Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022279Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022279Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022279Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022279s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022279Orig1s003; 022424Orig1s003ltr.pdf
06/28/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022279s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022279Orig1s002,022424Orig1s002ltr.pdf
01/13/2017	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022279s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022279Orig1s001,022424Orig1s001ltr.pdf

Labels for NDA 022279

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022279s003lbl.pdf
06/28/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022279s002lbl.pdf
01/13/2017	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022279s001lbl.pdf
01/13/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022279s001lbl.pdf
05/14/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022279Orig1s000lbl.pdf

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