FDA.reportPublic FDA data

Application 020898

Type
BLA
Sponsor
GENZYME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THYROGENTHYROTROPIN ALFAINJECTABLE;INJECTION1.1MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0030ThyrogenTHYROTROPIN ALFAGenzyme CorporationBLACurrent
58468-0030ThyrogenTHYROTROPIN ALFAGenzyme CorporationBLACurrent
58468-0030ThyrogenTHYROTROPIN ALFAGenzyme CorporationNDACurrent
58468-1849ThyrogenTHYROTROPIN ALFAGenzyme CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66725ORIG2021-03-10
62141SUPPL2020-03-23
62140SUPPL2020-03-23
62139SUPPL2020-03-23
62138SUPPL2020-03-23
48147SUPPL2020-03-23
48096SUPPL2020-03-23
41791ORIG2020-03-23
35598SUPPL2020-03-23
35597SUPPL2020-03-23
35596ORIG2020-03-23
26143SUPPL2020-03-23
26142SUPPL2020-03-23
26141SUPPL2020-03-23
13697SUPPL2020-03-23
13696SUPPL2020-03-23
13695SUPPL2020-03-23
13694SUPPL2020-03-23
3688SUPPL2020-03-23
3687SUPPL2020-03-23
3686SUPPL2020-03-23
3685ORIG2020-03-23
66429APPL2020-03-22