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FDA Approval

Acthrel

CompanyFerring Pharmaceuticals Inc. (DUNS: 103722955)

Effective Date

November 12, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Corticorelin ovine triflutate(100 ug in 2 mL)

Products (1)

Acthrel

NDC Product Code

55566-0302

Application Number

BLA020162

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

November 12, 2021

Ingredients

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACTQuantity: 0.88 mg in 2 mL

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CYSTEINE HYDROCHLORIDEInactive

Code: ZT934N0X4WClass: IACT

Corticorelin ovine triflutateActive

Code: 56X54T817QClass: ACTIMQuantity: 100 ug in 2 mL

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