FDA.reportPublic FDA data

Application 091646

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLATIRAMER ACETATEGLATIRAMER ACETATEINJECTABLE;SUBCUTANEOUS20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent
0378-6960Glatiramer Acetateglatiramer acetateMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49959ORIG2017-10-05