Jeuveau
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2019
Approved
Approval ID
17a914c1-e54b-4b50-965d-b0fd9111bba4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
Evolus, Inc.
DUNS: 842821881
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prabotulinum Toxin Type A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72301-595
Application NumberBLA761085
Product Classification
M
Marketing Category
C73585
G
Generic Name
Prabotulinum Toxin Type A
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateFebruary 13, 2019
FDA Product Classification
INGREDIENTS (3)
BOTULINUM TOXIN TYPE AActive
Quantity: 100 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT