FDA.reportPublic FDA data

Application 125274

Type
BLA
Sponsor
IPSEN BIOPHARM LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYSPORTabobotulinumtoxinAINJECTABLE; INJECTION500 UNITS/VIALNoNo
002DYSPORTabobotulinumtoxinAINJECTABLE; INJECTION300 UNITS/VIALNoNo

NDC Listings For This Application#

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