FDA.report

Application 209321

Type
NDA
Sponsor
JACOBUS PHARM CO INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001RUZURGIAMIFAMPRIDINETABLET;ORAL10MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
49938-110RuzurgiAmifampridineJacobus Pharmaceutical Company,IncNDACurrent
49938-110RuzurgiAmifampridineJacobus Pharmaceutical Company,IncNDACurrent
49938-110RUZURGIamifampridineJacobus Pharmaceutical Company, Inc.NDACurrent

Documents

DocumentSubmission typeDate
70076ORIG2022-02-04
64398SUPPL2020-08-24
59050ORIG2019-06-13
58601ORIG2019-05-07
58600ORIG2019-05-07
58597ORIG2019-05-07
58596ORIG2019-05-07