FDA.reportPublic FDA data

Application 210158

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DALFAMPRIDINEDALFAMPRIDINETABLET, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-275DALFAMPRIDINEDALFAMPRIDINEMicro Labs LimitedANDACurrent
42571-275DALFAMPRIDINEDALFAMPRIDINEMicro Labs LimitedANDACurrent
42571-275DALFAMPRIDINEDALFAMPRIDINEMicro Labs LimitedANDACurrent
42571-275DALFAMPRIDINEDALFAMPRIDINEMicro Labs LimitedANDACurrent
42571-275DALFAMPRIDINEDALFAMPRIDINEMicro Labs LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57742ORIG2019-02-21
55241ORIG2018-08-20