FDA.reportPublic FDA data

Application 020898

Type
BLA
Sponsor
GENZYME

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020898Thyrogenthyrotropin alfa351(a)Rx2026-09-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThyrogenTHYROTROPIN ALFAGenzyme Corporationb52dfa36-f90b-4e19-9b5e-26db9d04df2b2023-02-24Warnings, Adverse reactionsExact identifier
application number: BLA020898
ndc (product): 58468-1849
ndc (product): 58468-0030

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

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