MedPath
FDA Approval

PRIALT

October 30, 2023

HUMAN PRESCRIPTION DRUG LABEL

Ziconotide Acetate(100 ug in 1 mL)

Products (3)

PRIALT

70720-720

NDA021060

NDA (C73594)

INTRATHECAL

August 15, 2019

Code: T2I226K69MClass: ACTIMQuantity: 100 ug in 1 mL
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT

PRIALT

70720-723

NDA021060

NDA (C73594)

INTRATHECAL

August 15, 2019

METHIONINEInactive
Code: AE28F7PNPLClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: T2I226K69MClass: ACTIMQuantity: 25 ug in 1 mL

PRIALT

70720-722

NDA021060

NDA (C73594)

INTRATHECAL

August 15, 2019

Code: T2I226K69MClass: ACTIMQuantity: 100 ug in 1 mL
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
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