FDA.reportPublic FDA data

Application 202317

Type
NDA
Sponsor
HELSINN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALCHLORMECHLORETHAMINE HYDROCHLORIDEGEL;TOPICALEQ 0.016% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66215-001Non-medicated VALCHLOR DemonstrationNon-medicated VALCHLOR DemonstrationActelion Pharmaceuticals US, Inc.NDACurrent
66215-016VALCHLORmechlorethamine hydrochlorideActelion Pharmaceuticals US, Inc.NDACurrent
69639-120VALCHLORmechlorethamine hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-120VALCHLORmechlorethamine hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-120VALCHLORmechlorethamine hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-120VALCHLORmechlorethamine hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-120VALCHLORmechlorethamine hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-120VALCHLORmechlorethamine hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62821SUPPL2020-05-05
62811SUPPL2020-05-04
61810SUPPL2020-02-06
61809SUPPL2020-02-06
61566SUPPL2020-01-28
40166SUPPL2015-11-04
32232SUPPL2015-11-03
24415ORIG2014-03-14
22885ORIG2014-03-14
23491ORIG2013-08-30
40165ORIG2013-08-27
32231ORIG2013-08-27