Vagifem
These highlights do not include all the information needed to use VAGIFEM safely and effectively. See full prescribing information for VAGIFEM.Vagifem (estradiol vaginal inserts)Initial U.S. Approval: 1999
Approved
Approval ID
e5ad3cf6-dd96-4e64-af21-c1eee38d0b88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-5176
Application NumberNDA020908
Product Classification
M
Marketing Category
C73594
G
Generic Name
estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateDecember 17, 2020
FDA Product Classification
INGREDIENTS (1)
ESTRADIOLActive
Quantity: 10 ug in 1 1
Code: 4TI98Z838E
Classification: ACTIB