FDA.reportPublic FDA data

Application 210607

Type
NDA
Sponsor
60 DEGREES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARAKODATAFENOQUINE SUCCINATETABLET;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71475-257ArakodaTafenoquine60 Degrees Pharmaceuticals, LLCNDACurrent
71475-257ArakodaTafenoquine60 Degrees Pharmaceuticals, LLCNDACurrent
71475-257ArakodaTafenoquine60 Degrees Pharmaceuticals, LLCNDACurrent
71475-257ArakodaTafenoquine60 Degrees Pharmaceuticals, LLCNDACurrent
71475-257ArakodaTafenoquine60 Degrees Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57584ORIG2019-02-13
55162ORIG2018-08-10
55138ORIG2018-08-08