FDA.reportPublic FDA data

Application 125360

Type
BLA
Sponsor
MERZ PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XeominincobotulinumtoxinAINJECTABLE; INJECTION50 UNITS/VIALNoNo
002XeominincobotulinumtoxinAINJECTABLE; INJECTION100 UNITS/VIALNoNo
003XeominincobotulinumtoxinAINJECTABLE;INJECTION200 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1605XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1610XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-1620XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4110XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
0259-4150XeominincobotulinumtoxinAMerz Pharmaceuticals, LLCBLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-160XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-161XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent
46783-165XeominincobotulinumtoxinAMerz North America, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85524SUPPL 2026-03-25
85523SUPPL 2026-03-25
85183SUPPL 2026-03-02
85182SUPPL 2026-03-02
84472SUPPL 2025-12-19
84471SUPPL 2025-12-19
75447SUPPL 2023-09-13
75386SUPPL 2023-09-11
68394SUPPL2021-08-17
68393SUPPL2021-08-17
68374SUPPL2021-08-16
67130SUPPL2021-04-22
67129SUPPL2021-04-22
67128SUPPL2021-04-22
67127SUPPL2021-04-22
67126SUPPL2021-04-22
67123SUPPL2021-04-20
67122SUPPL2021-04-20
67121SUPPL2021-04-20
67120SUPPL2021-04-20
67119SUPPL2021-04-20
65674SUPPL2020-12-22
65673SUPPL2020-12-22
65632SUPPL2020-12-21
65631SUPPL2020-12-21
65630SUPPL2020-12-21
65629SUPPL2020-12-21
64305SUPPL2020-08-19
64304SUPPL2020-08-19
64300SUPPL2020-08-19
58702SUPPL2019-05-14
58701SUPPL2019-05-14
58674SUPPL2019-05-14
54782SUPPL2018-07-06
54742SUPPL2018-07-03
31941SUPPL2015-12-29
39938SUPPL2015-12-28
18887SUPPL2015-11-25
18886SUPPL2013-04-16
9722SUPPL2013-04-16
9721SUPPL2012-07-18
18885SUPPL2011-07-25
24364ORIG2011-02-17
22804ORIG2010-09-29
31940SUPPL2010-08-06
18884SUPPL2010-08-06
18883ORIG2010-08-06
9720ORIG2010-08-06