FDA.reportPublic FDA data

Application 103000

Type
BLA
Sponsor
ALLERGAN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103000Botox CosmeticonabotulinumtoxinA351(a)Rx2026-07-01

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOTOXONABOTULINUMTOXINASportpharm LLCa6f42753-d31e-4b23-8da0-4b990fee4b382026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
BOTOX CosmeticONABOTULINUMTOXINAAllergan, Inc.485d9b71-6881-42c5-a620-a4360c7192ab2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
ndc (product): 0023-3919
ndc (product): 0023-9232
BOTOXONABOTULINUMTOXINAAllergan, Inc.33d066a9-34ff-4a1a-b38b-d10983df33002023-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
ndc (product): 0023-3921
ndc (product): 0023-1145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

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