Application 125360

Type: BLA
Sponsor: MERZ PHARMS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125360	Xeomin	incobotulinumtoxinA	351(a)	Rx	2026-08-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	Xeomin	incobotulinumtoxinA	INJECTABLE; INJECTION	50 UNITS/VIAL	No	No
002	Xeomin	incobotulinumtoxinA	INJECTABLE; INJECTION	100 UNITS/VIAL	No	No
003	Xeomin	incobotulinumtoxinA	INJECTABLE;INJECTION	200 UNITS/VIAL	No	No

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xeomin	INCOBOTULINUMTOXINA	Merz Pharmaceuticals, LLC	ccdc3aae-6e2d-4cd0-a51c-8375bfee9458	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125360 ndc (product): 0259-4150 ndc (product): 0259-1610 ndc (product): 0259-4110 ndc (product): 0259-1620 ndc (product): 0259-1605
Xeomin	INCOBOTULINUMTOXINA	Merz North America, Inc.	3f35d6e0-3450-4abc-a0da-cc7b277e7c6e	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125360 ndc (product): 46783-161 ndc (product): 46783-165 ndc (product): 46783-160

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85524	SUPPL	2026-03-25
85523	SUPPL	2026-03-25
85183	SUPPL	2026-03-02
85182	SUPPL	2026-03-02
84472	SUPPL	2025-12-19
84471	SUPPL	2025-12-19
75447	SUPPL	2023-09-13
75386	SUPPL	2023-09-11
68394	SUPPL	2021-08-17
68393	SUPPL	2021-08-17
68374	SUPPL	2021-08-16
67130	SUPPL	2021-04-22
67129	SUPPL	2021-04-22
67128	SUPPL	2021-04-22
67127	SUPPL	2021-04-22
67126	SUPPL	2021-04-22
67123	SUPPL	2021-04-20
67122	SUPPL	2021-04-20
67121	SUPPL	2021-04-20
67120	SUPPL	2021-04-20
67119	SUPPL	2021-04-20
65674	SUPPL	2020-12-22
65673	SUPPL	2020-12-22
65632	SUPPL	2020-12-21
65631	SUPPL	2020-12-21
65630	SUPPL	2020-12-21
65629	SUPPL	2020-12-21
64305	SUPPL	2020-08-19
64304	SUPPL	2020-08-19
64300	SUPPL	2020-08-19
58702	SUPPL	2019-05-14
58701	SUPPL	2019-05-14
58674	SUPPL	2019-05-14
54782	SUPPL	2018-07-06
54742	SUPPL	2018-07-03
31941	SUPPL	2015-12-29
39938	SUPPL	2015-12-28
18887	SUPPL	2015-11-25
18886	SUPPL	2013-04-16
9722	SUPPL	2013-04-16
9721	SUPPL	2012-07-18
18885	SUPPL	2011-07-25
24364	ORIG	2011-02-17
22804	ORIG	2010-09-29
31940	SUPPL	2010-08-06
18884	SUPPL	2010-08-06
18883	ORIG	2010-08-06
9720	ORIG	2010-08-06