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
df731acd-7276-4fef-b037-bc7f30c112cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2020
Manufacturers
FDA
AMAG Pharmaceuticals, Inc.
DUNS: 017511155
Products 1
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 Code64011-601
Application NumberNDA208470
Product Classification
M
Marketing Category
C73594
G
Generic Name
Prasterone
Product Specifications
Route of AdministrationVAGINAL
Effective DateJune 20, 2017
FDA Product Classification
INGREDIENTS (2)
PRASTERONEActive
Quantity: 6.5 mg in 1 1
Code: 459AG36T1B
Classification: ACTIB
HYDROGENATED COCO-GLYCERIDESInactive
Code: XDD37N2GPR
Classification: IACT