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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202317
Company: HELSINN

Medication Guide

Summary Review

Products on NDA 202317

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALCHLOR	MECHLORETHAMINE HYDROCHLORIDE	EQ 0.016% BASE	GEL;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202317

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202317Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202317Orig1s010ltr.pdf
01/13/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202317Orig1s009ltredt.pdf
12/22/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/08/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/29/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202317s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202317Orig1s004ltr.pdf
10/13/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/08/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/09/2014	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 202317

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s010lbl.pdf
01/13/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s009lbl.pdf
10/29/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202317s004lbl.pdf
08/23/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf

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