Registrants (1)
Novast Laboratories , Ltd.
527695995
Manufacturing Establishments (1)
Ingenus Pharmaceuticals GmbH
Ingenus Pharmaceuticals, LLC
Novast Laboratories , Ltd.
482730327
Products (2)
Irinotecan Hydrochloride
50742-402
ANDA206935
ANDA (C73584)
INTRAVENOUS
July 8, 2022
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 100 mg in 5 mL
SORBITOLInactive
Code: 506T60A25RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Irinotecan Hydrochloride
50742-401
ANDA206935
ANDA (C73584)
INTRAVENOUS
July 8, 2022
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
IrinotecanActive
Code: 042LAQ1IISClass: ACTIBQuantity: 40 mg in 2 mL
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT