BESREMi

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

PharmaEssentia USA

DUNS Number

658873411

Labeler

PharmaEssentia USA

DUNS Number

783409162

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

73536-500

Application Number

BLA761166

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS

Effective Date

January 12, 2024

Ingredients

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 981TME683SClass: ACTIBQuantity: 500 ug in 1 mL