FDA.reportPublic FDA data

Application 009170

Type
NDA
Sponsor
VALEANT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MYSOLINEPRIMIDONETABLET;ORAL250MGYesNo
003MYSOLINEPRIMIDONETABLET;ORAL50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66490-690MysolinePrimidoneValeant Pharmaceuticals North AmericaNDACurrent
66490-690MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-690MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-690MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-690MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-691MysolinePrimidoneValeant Pharmaceuticals North AmericaNDACurrent
66490-691MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-691MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-691MysolinePrimidoneBausch Health US, LLCNDACurrent
66490-691MysolinePrimidoneBausch Health US, LLCNDACurrent
68682-690PrimidonePrimidoneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-690PrimidonePrimidoneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-691PrimidonePrimidoneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-691PrimidonePrimidoneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64846SUPPL2020-10-06
64845SUPPL2020-10-06
64818SUPPL2020-10-05
11866SUPPL2011-08-12
23090SUPPL2010-07-30
10719SUPPL2010-07-30
129SUPPL2010-07-23
32987SUPPL2009-10-15
32988SUPPL2009-05-13
128SUPPL2009-05-13
11865SUPPL2009-05-01
127SUPPL2009-02-03
11864SUPPL2008-06-16