ANNOVERA
These highlights do not include all the information needed to use ANNOVERA safely and effectively. See Full Prescribing Information for ANNOVERA. ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)Initial U.S. Approval: 2018
Approved
Approval ID
37bb9ebd-2e99-4453-bbe6-9dd4a2897193
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2022
Manufacturers
FDA
TherapeuticsMD, Inc.
DUNS: 072998685
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
segesterone acetate and ethinyl estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50261-313
Application NumberNDA209627
Product Classification
M
Marketing Category
C73594
G
Generic Name
segesterone acetate and ethinyl estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 13, 2021
FDA Product Classification
INGREDIENTS (4)
segesterone acetateActive
Quantity: 103 mg in 1 1
Code: 9AMX4Q13CC
Classification: ACTIB
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ethinyl estradiolActive
Quantity: 17.4 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
dibutyltin dilaurateInactive
Code: L4061GMT90
Classification: IACT