FDA.reportPublic FDA data

Application 125274

Type
BLA
Sponsor
IPSEN BIOPHARM LTD

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125274DysportabobotulinumtoxinA351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYSPORTabobotulinumtoxinAINJECTABLE; INJECTION500 UNITS/VIALNoNo
002DYSPORTabobotulinumtoxinAINJECTABLE; INJECTION300 UNITS/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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DysportBOTULINUM TOXIN TYPE AGalderma Laboratories, L.P.71313a04-1349-4c26-b840-a39e4a3ddaed2024-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125274
ndc (product): 0299-5962
DysportBOTULINUM TOXIN TYPE AIpsen Biopharmaceuticals, Inc.97513722-8426-4ce3-b85d-0e08e436a1402023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125274
ndc (product): 15054-0500
ndc (product): 15054-0530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5962DysportBotulinum Toxin Type AGalderma Laboratories, L.P.BLACurrent
0299-5962DysportBotulinum Toxin Type AGalderma Laboratories, L.P.BLACurrent
0299-5962DysportBotulinum Toxin Type AGalderma Laboratories, L.P.BLACurrent
0299-5962DysportBotulinum Toxin Type AGalderma Laboratories, L.P.BLACurrent
0299-5962DysportBotulinum Toxin Type AGalderma Laboratories, L.P.BLACurrent
15054-0500DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0500DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0500DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0500DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0530DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0530DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0530DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent
15054-0530DysportBotulinum Toxin Type AIpsen Biopharmaceuticals, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75544SUPPL 2023-09-22
75543SUPPL 2023-09-22
75534SUPPL 2023-09-22
73150SUPPL2023-01-13
73149SUPPL2023-01-13
73148SUPPL2023-01-13
64946SUPPL2020-10-20
64938SUPPL2020-10-20
64936SUPPL2020-10-20
63947SUPPL2020-07-17
60124SUPPL2019-09-26
60123SUPPL2019-09-26
60114SUPPL2019-09-26
56466SUPPL2018-11-15
56317SUPPL2018-11-06
48771SUPPL2017-06-19
48718SUPPL2017-06-15
46130SUPPL2016-12-13
46127SUPPL2016-12-13
31884SUPPL2016-08-02
18834SUPPL2016-08-02
31883SUPPL2015-07-16
44428ORIG2013-04-05
39890SUPPL2012-05-23
9661SUPPL2012-05-23
44795ORIG2011-08-17
43313SUPPL2011-08-17
24359SUPPL2011-08-17
22794ORIG2011-08-17
39889ORIG2009-06-04
18832SUPPL2009-06-04
31882SUPPL2009-05-07
31881ORIG2009-05-07
62863SUPPL1900-01-01
62862SUPPL1900-01-01
51424SUPPL1900-01-01
51421SUPPL1900-01-01
51390SUPPL1900-01-01