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FDA Approval

ANNOVERA

CompanyTherapeuticsMD, Inc. (DUNS: 072998685)

Effective Date

August 23, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Segesterone acetate(103 mg in 1 1)

Ethinylestradiol(17.4 mg in 1 1)

Manufacturing Establishments (1)

Labeler

TherapeuticsMD, Inc.

DUNS Number

508638848

Products (1)

ANNOVERA

NDC Product Code

50261-313

Application Number

NDA209627

Marketing Category

NDA (C73594)

Route of Administration

VAGINAL

Effective Date

January 13, 2021

Ingredients

Segesterone acetateActive

Code: 9AMX4Q13CCClass: ACTIBQuantity: 103 mg in 1 1

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

EthinylestradiolActive

Code: 423D2T571UClass: ACTIBQuantity: 17.4 mg in 1 1

dibutyltin dilaurateInactive

Code: L4061GMT90Class: IACT

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