FDA.reportPublic FDA data

Application 083551

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMIDONEPRIMIDONETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5321PrimidonePrimidoneActavis Pharma, Inc.ANDACurrent
0591-5321PrimidonePrimidoneActavis Pharma, Inc.ANDACurrent
50090-1622PrimidonePrimidoneA-S Medication SolutionsANDACurrent