Manufacturing Establishments (1)
Gland Pharma Limited
Gland Pharma Limited
650540227
Products (2)
Irinotecan hydrochloride
68083-382
ANDA212993
ANDA (C73584)
INTRAVENOUS
March 3, 2022
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Irinotecan hydrochloide
68083-381
ANDA212993
ANDA (C73584)
INTRAVENOUS
March 3, 2022
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT