Manufacturing Establishments (1)
Qilu Pharmaceutical (Hainan) Co., Ltd.
Qilu Pharmaceutical Co., Ltd.
529131725
Products (3)
Irinotecan Hydrochloride
67184-0512
ANDA203380
ANDA (C73584)
INTRAVENOUS
April 15, 2020
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
Irinotecan Hydrochloride
67184-0513
ANDA203380
ANDA (C73584)
INTRAVENOUS
April 15, 2020
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACT
Irinotecan Hydrochloride
67184-0511
ANDA203380
ANDA (C73584)
INTRAVENOUS
April 15, 2020
SORBITOLInactive
Code: 506T60A25RClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL