MedPath
FDA Approval

Hemabate

January 10, 2022

HUMAN PRESCRIPTION DRUG LABEL

Carboprost tromethamine(250 ug in 1 mL)

Manufacturing Establishments (1)

Pharmacia & Upjohn Company LLC

Pharmacia & Upjohn Company LLC

618054084

Products (1)

Hemabate

0009-0856

NDA017989

NDA (C73594)

INTRAMUSCULAR

January 10, 2022

Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 83 ug in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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