FDA.reportPublic FDA data

Application 091032

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

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
0143-9583Irinotecan HydrochlorideIrinotecan HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9583Irinotecan HydrochlorideIrinotecan HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9583Irinotecan HydrochlorideIrinotecan HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9701Irinotecan HydrochlorideIrinotecan HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9701Irinotecan HydrochlorideIrinotecan HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9701Irinotecan HydrochlorideIrinotecan HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9702Irinotecan HydrochlorideIrinotecan HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9702Irinotecan HydrochlorideIrinotecan HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9702Irinotecan HydrochlorideIrinotecan HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent