Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
IPSEN BIOPHARM LTD
Ipsen Biopharmaceuticals, Inc.
365113203
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dysport
Product Details
NDC Product Code
15054-0500Application Number
BLA125274Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
September 28, 2023albumin humanInactive
Code: ZIF514RVZRClass: IACT
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 500 U in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Dysport
Product Details
NDC Product Code
15054-0530Application Number
BLA125274Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
September 28, 2023Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 300 U in 1 1
albumin humanInactive
Code: ZIF514RVZRClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT