Intrarosa
These highlights do not include all the information needed to use INTRAROSA safely and effectively. See full prescribing information for INTRAROSA . INTRAROSA (prasterone) vaginal inserts Initial U.S. Approval: 2016
Approved
Approval ID
ada639d4-bac0-2ad0-e053-2a95a90afce7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2023
Manufacturers
FDA
Millicent US, Inc.
DUNS: 081309152
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prasterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72495-401
Application NumberNDA208470
Product Classification
M
Marketing Category
C73594
G
Generic Name
Prasterone
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (2)
HYDROGENATED COCO-GLYCERIDESInactive
Code: XDD37N2GPR
Classification: IACT
PRASTERONEActive
Quantity: 6.5 mg in 1 1
Code: 459AG36T1B
Classification: ACTIB
Prasterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72495-501
Application NumberNDA208470
Product Classification
M
Marketing Category
C73594
G
Generic Name
Prasterone
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (2)
PRASTERONEActive
Quantity: 6.5 mg in 1 1
Code: 459AG36T1B
Classification: ACTIB
HYDROGENATED COCO-GLYCERIDESInactive
Code: XDD37N2GPR
Classification: IACT