FDA.reportPublic FDA data

Application 040719

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION40MG/MLNoNo
002METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION80MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3136Methylprednisolone AcetateMethylprednisolone AcetateSandoz IncANDACurrent
0781-3137Methylprednisolone AcetateMethylprednisolone AcetateSandoz IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22152ORIG2013-05-10