Manufacturing Establishments (2)
Zambon Switzerland Ltd
Fresenius Kabi USA, LLC
481761344
ACS Dobfar S.p.A.
Fresenius Kabi USA, LLC
439962157
Products (2)
Imipenem and Cilastatin
63323-349
ANDA090577
ANDA (C73584)
INTRAVENOUS
August 31, 2020
ImipenemActive
Code: 71OTZ9ZE0AClass: ACTIMQuantity: 250 mg in 20 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 10 mg in 20 mL
CilastatinActive
Code: 5428WXZ74MClass: ACTIMQuantity: 250 mg in 20 mL
Imipenem and Cilastatin
63323-322
ANDA090577
ANDA (C73584)
INTRAVENOUS
August 31, 2020
CilastatinActive
Code: 5428WXZ74MClass: ACTIMQuantity: 500 mg in 20 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 20 mg in 20 mL
ImipenemActive
Code: 71OTZ9ZE0AClass: ACTIMQuantity: 500 mg in 20 mL