FDA.reportPublic FDA data

Application 103000

Type
BLA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BOTOXOnabotulinumtoxinAVIAL; SINGLE-USE50 UNITS/VIALNoNo
002BOTOXOnabotulinumtoxinAVIAL; SINGLE-USE100 UNITS/VIALNoNo
003BOTOXOnabotulinumtoxinAVIAL; SINGLE-USE200 UNITS/VIALNoNo
004BOTOX COSMETICOnabotulinumtoxinAVIAL; SINGLE-USE50 UNITS/VIALNoNo
005BOTOX COSMETICOnabotulinumtoxinAVIAL; SINGLE-USE100 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-1145BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3919BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-3921BOTOXonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent
0023-9232BOTOX CosmeticonabotulinumtoxinAAllergan, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79967SUPPL 2024-10-23
79966SUPPL 2024-10-23
79965SUPPL 2024-10-23
79964SUPPL 2024-10-23
79963SUPPL 2024-10-23
79921SUPPL 2024-10-21
79920SUPPL 2024-10-21
79919SUPPL 2024-10-21
79918SUPPL 2024-10-21
79917SUPPL 2024-10-21
76040SUPPL 2023-11-02
75113SUPPL 2023-08-17
75112SUPPL 2023-08-17
75064SUPPL 2023-08-14
75044SUPPL 2023-08-11
71944SUPPL2022-08-29
71888SUPPL2022-08-25
71887SUPPL2022-08-25
68221SUPPL2021-07-29
68216SUPPL2021-07-28
68215SUPPL2021-07-28
66171SUPPL2021-02-10
66170SUPPL2021-02-09
66169SUPPL2021-02-09
64948SUPPL2020-10-20
64947SUPPL2020-10-20
64945SUPPL2020-10-20
64596SUPPL2020-09-17
64576SUPPL2020-09-15
64571SUPPL2020-09-14
63948SUPPL2020-07-17
61259SUPPL2019-12-12
60615SUPPL2019-10-22
60605SUPPL2019-10-21
60604SUPPL2019-10-21
59155SUPPL2019-06-21
59142SUPPL2019-06-21
55481SUPPL2018-09-14
54265SUPPL2018-05-21
54227SUPPL2018-05-17
54224SUPPL2018-05-17
49958SUPPL2017-10-05
49934SUPPL2017-10-03
48422SUPPL2017-05-17
48078SUPPL2017-04-21
48073SUPPL2017-04-21
47942SUPPL2017-04-12
47941SUPPL2017-04-12
47940SUPPL2017-04-12
47858SUPPL2017-04-05
47857SUPPL2017-04-05
47856SUPPL2017-04-05
9363SUPPL2016-02-05
18552SUPPL2016-01-26
31553SUPPL2016-01-22
43260SUPPL2015-09-23
39628SUPPL2015-08-12
9362SUPPL2015-08-12
31552SUPPL2015-08-10
18551SUPPL2015-08-07
39627SUPPL2015-04-21
31556SUPPL2015-04-21
31555SUPPL2014-05-08
43258SUPPL2013-10-23
18554SUPPL2013-09-17
31554SUPPL2013-09-13
43259SUPPL2013-08-09
39626SUPPL2013-01-23
9359SUPPL2013-01-23
18553SUPPL2012-11-14
9360SUPPL2012-11-14
9361SUPPL2012-07-18
39624SUPPL2011-08-30
31551SUPPL2011-08-30
39625SUPPL2011-07-08
9358SUPPL2010-10-20
18550SUPPL2010-10-19
31549SUPPL2010-03-18
18548SUPPL2010-03-17
39623SUPPL2009-08-07
31550SUPPL2009-08-07
18549SUPPL2009-08-07
9357SUPPL2009-08-07
44421ORIG2008-08-12
39622SUPPL2004-09-15
9356SUPPL2004-07-21
43257SUPPL2004-03-11
43256SUPPL2004-03-11
31548SUPPL2004-03-11
18547SUPPL2004-03-11
9355SUPPL2004-03-11
63212SUPPL1900-01-01
63211SUPPL1900-01-01
63210SUPPL1900-01-01
63209SUPPL1900-01-01
63208SUPPL1900-01-01