MedPath
FDA Approval

PRIMAXIN

December 1, 2023

HUMAN PRESCRIPTION DRUG LABEL

Imipenem(500 mg in 100 mL)
Cilastatin(500 mg in 100 mL)

Products (4)

PRIMAXIN IV

0006-3516

NDA050587

NDA (C73594)

INTRAVENOUS

May 24, 2022

ImipenemActive
Code: 71OTZ9ZE0AClass: ACTIMQuantity: 500 mg in 100 mL
Code: 5428WXZ74MClass: ACTIMQuantity: 500 mg in 100 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 20 mg in 100 mL

PRIMAXIN IV

0006-3552

ANDA062756

ANDA (C73584)

INTRAVENOUS

May 24, 2022

ImipenemActive
Code: 71OTZ9ZE0AClass: ACTIMQuantity: 500 mg in 100 mL
Code: 5428WXZ74MClass: ACTIMQuantity: 500 mg in 100 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 20 mg in 100 mL

PRIMAXIN IV

0006-3514

NDA050587

NDA (C73594)

INTRAVENOUS

May 24, 2022

ImipenemActive
Code: 71OTZ9ZE0AClass: ACTIMQuantity: 250 mg in 100 mL
Code: 5428WXZ74MClass: ACTIMQuantity: 250 mg in 100 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 10 mg in 100 mL

PRIMAXIN IV

0006-3551

ANDA062756

ANDA (C73584)

INTRAVENOUS

May 24, 2022

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 10 mg in 100 mL
ImipenemActive
Code: 71OTZ9ZE0AClass: ACTIMQuantity: 250 mg in 100 mL
Code: 5428WXZ74MClass: ACTIMQuantity: 250 mg in 100 mL
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