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FDA Approval

Intrarosa

CompanyAMAG Pharmaceuticals, Inc. (DUNS: 017511155)

Effective Date

November 11, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Prasterone(6.5 mg in 1 1)

Products (1)

Intrarosa

NDC Product Code

64011-601

Application Number

NDA208470

Marketing Category

NDA (C73594)

Route of Administration

VAGINAL

Effective Date

June 20, 2017

Ingredients

PrasteroneActive

Code: 459AG36T1BClass: ACTIBQuantity: 6.5 mg in 1 1

HYDROGENATED COCO-GLYCERIDESInactive

Code: XDD37N2GPRClass: IACT

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