FDA.reportPublic FDA data

Application 203380

Type
ANDA
Sponsor
QILU

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
003IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION300MG/15ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
60505-6128Irinotecan HydrochlorideIrinotecan HydrochlorideApotex Corp.ANDACurrent
67184-0511Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0511Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0511Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0512Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0512Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0512Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0513Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0513Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0513Irinotecan HydrochlorideIrinotecan HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10202ORIG2016-05-06