FDA.reportPublic FDA data

Application 040194

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONEMETHYLPREDNISOLONETABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5022MethylprednisoloneMethylprednisoloneSandoz IncANDACurrent
0781-5022MethylprednisoloneMethylprednisoloneSandoz IncANDACurrent
0781-5022MethylprednisoloneMethylprednisoloneSandoz IncANDACurrent
45865-104MethylprednisoloneMethylprednisoloneMedsource PharmaceuticalsANDACurrent
60760-373MethylprednisoloneMethylprednisoloneSt. Mary's Medical Park PharmacyANDACurrent
68071-2301MethylprednisoloneMethylprednisoloneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2301MethylprednisoloneMethylprednisoloneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4262MethylprednisoloneMethylprednisoloneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7343MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7343MethylprednisoloneMethylprednisolonePreferred Pharmaceuticals Inc.ANDACurrent
70518-1541MethylprednisoloneMethylprednisoloneREMEDYREPACK INC.ANDACurrent
70518-1541MethylprednisoloneMethylprednisoloneREMEDYREPACK INC.ANDACurrent
70518-1541MethylprednisoloneMethylprednisoloneREMEDYREPACK INC.ANDACurrent
70518-1541MethylprednisoloneMethylprednisoloneREMEDYREPACK INC.ANDACurrent
70518-1541MethylprednisoloneMethylprednisoloneREMEDYREPACK INC.ANDACurrent
71205-054MethylprednisoloneMethylprednisoloneProficient Rx LPANDACurrent
71205-054MethylprednisoloneMethylprednisoloneProficient Rx LPANDACurrent
71205-054MethylprednisoloneMethylprednisoloneProficient Rx LPANDACurrent
72189-008Methylpred DPMethylpred DPDirect_RxANDACurrent
72189-008Methylpred DPMethylpred DPDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22093ORIG2011-05-06