Dysport
These highlights do not include all the information needed to use DYSPORT safely and effectively. See full prescribing information for DYSPORT. DYSPORT (abobotulinumtoxinA) for injection, for intramuscular use Initial U.S. Approval: 2009
Approved
Approval ID
97513722-8426-4ce3-b85d-0e08e436a140
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2023
Manufacturers
FDA
Ipsen Biopharmaceuticals, Inc.
DUNS: 118461578
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Botulinum Toxin Type A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0500
Application NumberBLA125274
Product Classification
M
Marketing Category
C73585
G
Generic Name
Botulinum Toxin Type A
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (3)
albumin humanInactive
Code: ZIF514RVZR
Classification: IACT
Botulinum Toxin Type AActive
Quantity: 500 U in 1 1
Code: E211KPY694
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Botulinum Toxin Type A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0530
Application NumberBLA125274
Product Classification
M
Marketing Category
C73585
G
Generic Name
Botulinum Toxin Type A
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (3)
Botulinum Toxin Type AActive
Quantity: 300 U in 1 1
Code: E211KPY694
Classification: ACTIB
albumin humanInactive
Code: ZIF514RVZR
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT