Fensolvi
These highlights do not include all the information needed to use FENSOLVI safely and effectively. See full prescribing information for FENSOLVI.
Approved
Approval ID
dfb6e01c-f138-471d-bf5b-2be38247e3f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2022
Manufacturers
FDA
TOLMAR Inc.
DUNS: 791156578
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Leuprolide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62935-153
Application NumberNDA213150
Product Classification
M
Marketing Category
C73594
G
Generic Name
Leuprolide Acetate
Product Specifications
Effective DateDecember 5, 2023
FDA Product Classification