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FDA Approval

Zulresso

CompanySage Therapeutics, Inc. (DUNS: 968164959)

Effective Date

June 20, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Brexanolone(5 mg in 1 mL)

Products (1)

Zulresso

NDC Product Code

72152-547

Application Number

NDA211371

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

June 20, 2022

Ingredients

BrexanoloneActive

Code: S39XZ5QV8YClass: ACTIBQuantity: 5 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACTQuantity: 0.265 mg in 1 mL

BETADEX SULFOBUTYL ETHER SODIUMInactive

Code: 2PP9364507Class: IACTQuantity: 250 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 2.57 mg in 1 mL

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