incobotulinumtoxin A Injectable Solution

Brand(s)
Xeomin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merz North America, Inc (2015-08-10)
Oldest Current Product
2010-09-01
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\INCOBOTULINUMTOXIN A
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BOTULINUM TOXIN TYPE A
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BOTULINUM TOXIN TYPE A

product(s) by strength(s)

incobotulinumtoxin a 200 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002591605XeominBLAMerz Pharmaceuticals, Llc2010-09-01BOTULINUM TOXIN TYPE AINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125360ccdc3aae-6e2d-4cd0-a51c-8375bfee9458
2002591610XeominBLAMerz Pharmaceuticals, Llc2010-09-01BOTULINUM TOXIN TYPE AINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125360ccdc3aae-6e2d-4cd0-a51c-8375bfee9458
3002594150XeominBLAMerz Pharmaceuticals, Llc2010-09-01BOTULINUM TOXIN TYPE AINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125360ccdc3aae-6e2d-4cd0-a51c-8375bfee9458
4467830161XeominBLAMerz North America, Inc2011-08-01BOTULINUM TOXIN TYPE AINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1253603f35d6e0-3450-4abc-a0da-cc7b277e7c6e

application(s)

#idtitleapprovedtradenamesfda division
1125360incobotulinumtoxinA Application2010-07-30XeominCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13f35d6e0-3450-4abc-a0da-cc7b277e7c6e (view SPL)These highlights do not include all the information needed to use XEOMIN safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use Initial U.S. Approval: 2010prescriptionHuman PrescriptionMerz North America, IncANALYSIS, MANUFACTURE2015-08-107467830161, 467830160, 467830165
2ccdc3aae-6e2d-4cd0-a51c-8375bfee9458 (view SPL)These highlights do not include all the information needed to use XEOMIN safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use Initial U.S. Approval: 2010prescriptionHuman PrescriptionMerz Pharmaceuticals, LlcANALYSIS, MANUFACTURE2015-02-2712002591605, 002591610, 002594150, 002594110

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII