FDA.reportPublic FDA data

Application 125431

Type
BLA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TANZEUMALBIGLUTIDEINJECTABLE;INJECTION30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0866TanzeumalbiglutideGlaxoSmithKline LLCBLACurrent
0173-0867TanzeumalbiglutideGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50883SUPPL2017-12-27
50844SUPPL2017-12-22
50748SUPPL2017-12-18
49228SUPPL2017-08-03
49227SUPPL2017-08-03
49215SUPPL2017-08-02
45406SUPPL2016-09-15
45299SUPPL2016-09-15
9754SUPPL2015-07-28
9753SUPPL2015-05-11
39966SUPPL2015-05-08
9752SUPPL2015-03-11
24371ORIG2014-05-13
22810ORIG2014-05-13
24091ORIG2014-04-18
39965ORIG2014-04-17
9751ORIG2014-04-16