FDA.reportPublic FDA data

Application 209229

Type
NDA
Sponsor
US WORLDMEDS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUCEMYRALOFEXIDINE HYDROCHLORIDETABLET;ORALEQ 0.18MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27505-050Lucemyralofexidine hydrochlorideUS WorldMeds, LLCNDACurrent
27505-050Lucemyralofexidine hydrochlorideUS WorldMeds, LLCNDACurrent
27505-050Lucemyralofexidine hydrochlorideUS WorldMeds, LLCNDACurrent
27505-050Lucemyralofexidine hydrochlorideUS WorldMeds, LLCNDACurrent
78670-050Lucemyralofexidine hydrochlorideUSWM, LLCNDACurrent
78670-050Lucemyralofexidine hydrochlorideUSWM, LLCNDACurrent
78670-050Lucemyralofexidine hydrochlorideUSWM, LLCNDACurrent
78670-050Lucemyralofexidine hydrochlorideUSWM, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79557SUPPL 2024-09-06
79556SUPPL 2024-09-06
54725ORIG2018-06-28
54220ORIG2018-05-16
54219ORIG2018-05-16