FDA.reportPublic FDA data

Application 090101

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION500MG/25ML (20MG/ML)NoNo
002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION40MG/2ML (20MG/ML)NoNo
003IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION100MG/5ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-4432Irinotecan HydrochlorideIrinotecan HydrochlorideTeva Parenteral MedicinesANDACurrent
0703-4432Irinotecan HydrochlorideIrinotecan HydrochlorideTeva Parenteral Medicines, Inc.ANDACurrent
0703-4432Irinotecan HydrochlorideIrinotecan HydrochlorideTeva Parenteral Medicines, Inc.ANDACurrent
0703-4434Irinotecan HydrochlorideIrinotecan HydrochlorideTeva Parenteral MedicinesANDACurrent
0703-4434Irinotecan HydrochlorideIrinotecan HydrochlorideTeva Parenteral Medicines, Inc.ANDACurrent