FDA.reportPublic FDA data

Application 209321

Type
NDA
Sponsor
JACOBUS PHARM CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUZURGIAMIFAMPRIDINETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49938-110RuzurgiAmifampridineJacobus Pharmaceutical Company,IncNDACurrent
49938-110RuzurgiAmifampridineJacobus Pharmaceutical Company,IncNDACurrent
49938-110RUZURGIamifampridineJacobus Pharmaceutical Company, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70076ORIG2022-02-04
64398SUPPL2020-08-24
59050ORIG2019-06-13
58601ORIG2019-05-07
58600ORIG2019-05-07
58597ORIG2019-05-07
58596ORIG2019-05-07