FDA.reportPublic FDA data

Application 040620

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0043Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0045Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-0063Methylprednisolone AcetateMethylprednisolone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
16714-089Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-089Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-089Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-090Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-090Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-090Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-473Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-473Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
16714-473Methylprednisolone AcetateMethylprednisolone AcetateNorthstar RxLLCANDACurrent
50090-4463Methylprednisolone AcetateMethylprednisolone AcetateA-S Medication SolutionsANDACurrent
50090-4464Methylprednisolone AcetateMethylprednisolone AcetateA-S Medication SolutionsANDACurrent
53217-132Methylprednisolone AcetateMethylprednisolone AcetateAidarex Pharmaceuticals LLCANDACurrent
70518-2459Methylprednisolone AcetateMethylprednisolone AcetateREMEDYREPACK INC.ANDACurrent
70518-2459Methylprednisolone AcetateMethylprednisolone AcetateREMEDYREPACK INC.ANDACurrent
70518-2459Methylprednisolone AcetateMethylprednisolone AcetateREMEDYREPACK INC.ANDACurrent
70518-2914Methylprednisolone AcetateMethylprednisolone AcetateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44515ORIG2013-06-03
42633ORIG2012-06-26