MedPath
FDA Approval

Fosphenytoin Sodium

December 18, 2023

HUMAN PRESCRIPTION DRUG LABEL

Fosphenytoin Sodium(50 mg in 1 mL)

Manufacturing Establishments (1)

Strides Arcolab Limited

Amneal Pharmaceuticals LLC

918513263

Products (2)

Fosphenytoin Sodium

65162-999

ANDA078476

ANDA (C73584)

INTRAMUSCULAR, INTRAVENOUS

December 18, 2023

WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 7VLR55452ZClass: ACTIRQuantity: 50 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Fosphenytoin Sodium

65162-998

ANDA078476

ANDA (C73584)

INTRAMUSCULAR, INTRAVENOUS

December 18, 2023

WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 7VLR55452ZClass: ACTIRQuantity: 50 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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