FDA.reportPublic FDA data

Application 209808

Type
ANDA
Sponsor
PIRAMAL HLTHCARE UK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBAZAMCLOBAZAMTABLET;ORAL10MGNoNo
002CLOBAZAMCLOBAZAMTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-8013ClobazamClobazamSandoz Inc.ANDACurrent
0781-8013ClobazamClobazamSandoz Inc.ANDACurrent
0781-8013ClobazamClobazamSandoz Inc.ANDACurrent
0781-8014ClobazamClobazamSandoz Inc.ANDACurrent
0781-8014ClobazamClobazamSandoz Inc.ANDACurrent
0781-8014ClobazamClobazamSandoz Inc.ANDACurrent