FDA.reportPublic FDA data

Application 019599

Type
NDA
Sponsor
SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAFTINNAFTIFINE HYDROCHLORIDECREAM;TOPICAL1%YesNo
002NAFTINNAFTIFINE HYDROCHLORIDECREAM;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0259-4126NaftinNAFTIFINE HYDROCHLORIDEMerz Pharmaceuticals, LLCNDACurrent
40085-201Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDERenaissance Pharma, Inc.NDACurrent
40085-201Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDERenaissance Pharma, Inc.NDACurrent
40085-203Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDERenaissance Pharma, Inc.NDACurrent
40085-203Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDERenaissance Pharma, Inc.NDACurrent
40085-203Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDERenaissance Pharma, Inc.NDACurrent
54766-102NaftinNaftifine HydrochlorideSebela Pharmaceuticals Inc.NDACurrent
54766-102NaftinNaftifine HydrochlorideSebela Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62193SUPPL2020-03-19
53993SUPPL2018-05-03
53982SUPPL2018-05-02
45892SUPPL2016-11-15
45890SUPPL2016-11-14
40939SUPPL2015-11-05
11558SUPPL2014-10-15
17479SUPPL2014-10-14
11557SUPPL2012-01-23
17478SUPPL2012-01-18
1413SUPPL2009-01-30
51407SUPPL1900-01-01
51406SUPPL1900-01-01
51404SUPPL1900-01-01