Dichlorphenamide Oral Tablet

Brand(s)
Daranide, Keveyis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Taro Pharmaceuticals U.S.A., Inc. (2012-02-27)
Oldest Current Product
2012-03-16
License(s)
NDA
RxNORM
ORAL TABLET\DICHLORPHENAMIDE
FDAOB
ORAL\TABLET\DICHLORPHENAMIDE
SPL Active
ORAL\TABLET\DICHLORPHENAMIDE
SPL Moiety
ORAL\TABLET\DICHLORPHENAMIDE

product(s) by strength(s)

dichlorphenamide 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724144DaranideNDATaro Pharmaceuticals U.S.A., Inc.2012-03-16DICHLORPHENAMIDEORALTABLETNDA01136617f2f05d-7375-4d7d-8083-174ed27e736f

application(s)

#idtitleapplicantexclusivityapproved drug
1NDA011366DARANIDETARO PHARMACEUTICALS USA INCORPHAN DRUG EXCLUSIVITY [2022-08-07]NDA011366_001, NDA011366_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA011366_001discontinuedDICHLORPHENAMIDE (50MG)ORALTABLETFalseDARANIDE
2NDA011366_002RXDICHLORPHENAMIDE (50MG)ORALTABLETFalse2015-08-07DARANIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117f2f05d-7375-4d7d-8083-174ed27e736f (view SPL)These highlights do not include all the information needed to use DARANIDE (dichlorphenamide tablets USP) safely and effectively. See full prescribing information for DARANIDE (dichlorphenamide tablets USP). DARANIDE (dichlorphenamide tablets USP) Initial U.S. Approval: 1958prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-02-271516724144
24e274191-b1fc-43df-af35-beb5bbacc16c (view SPL)These highlights do not include all the information needed to use KEVEYIS safely and effectively. See full prescribing information for KEVEYIS. KEVEYIS (dichlorphenamide) tablets, for oral use Initial U.S. Approval: 1958prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-08-171516724177

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII