FDA.reportPublic FDA data

Application 090218

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3234GlatopaGlatiramer AcetateSandoz IncANDACurrent
0781-3234GlatopaGlatiramer AcetateSandoz IncANDACurrent
0781-3234GlatopaGlatiramer AcetateSandoz IncANDACurrent
0781-3234GlatopaGlatiramer AcetateSandoz IncANDACurrent
0781-3234GlatopaGlatiramer AcetateSandoz IncANDACurrent
0781-3234GlatopaGlatiramer AcetateSandoz IncANDACurrent
63629-8815GlatopaGlatiramer AcetateBryant Ranch PrepackANDACurrent
63629-8815GlatopaGlatiramer AcetateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52656ORIG2018-02-15
52655ORIG2018-02-15
31456ORIG2015-04-17
18534ORIG2015-04-16