FDA.reportPublic FDA data

Application 206936

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLATIRAMER ACETATEGLATIRAMER ACETATEINJECTABLE;SUBCUTANEOUS40MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent
0378-6961Glatiramer AcetateGlatiramerMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49969ORIG2017-10-06