FDA.reportPublic FDA data

Application 077915

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION40MG/2ML (20MG/ML)NoNo
002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION100MG/5ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61703-349Irinotecan HydrochlorideIrinotecan HydrochlorideHospira, Inc.ANDACurrent
61703-349Irinotecan HydrochlorideIrinotecan HydrochlorideHospira, Inc.ANDACurrent
61703-349Irinotecan HydrochlorideIrinotecan HydrochlorideHospira, Inc.ANDACurrent
61703-349Irinotecan HydrochlorideIrinotecan HydrochlorideHospira, Inc.ANDACurrent
61703-349Irinotecan HydrochlorideIrinotecan HydrochlorideHospira, Inc.ANDACurrent
61703-349Irinotecan HydrochlorideIrinotecan HydrochlorideHospira, Inc.ANDACurrent