YUVAFEM
These highlights do not include all the information needed to use YUVAFEM safely and effectively. See full prescribing information for YUVAFEM. YUVAFEM (estradiol vaginal inserts) Initial U.S. Approval: 1999
Approved
Approval ID
30c7f6ba-7a9e-4853-b3e4-e00a46560224
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-226
Application NumberANDA205256
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (6)
ESTRADIOLActive
Quantity: 10 ug in 1 1
Code: 4TI98Z838E
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT