FDA.reportPublic FDA data

Application 208313

Type
NDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1200MG BASE/120ML (EQ 10MG BASE/ML)YesYes
002INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1300MG BASE/130ML (EQ 10MG BASE/ML)YesYes
003INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1400MG BASE/140ML (EQ 10MG BASE/ML)YesYes
004INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1500MG BASE/150ML (EQ 10MG BASE/ML)YesYes
005INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1600MG BASE/160ML (EQ 10MG BASE/ML)YesYes
006INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1700MG BASE/170ML (EQ 10MG BASE/ML)YesYes
007INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1800MG BASE/180ML (EQ 10MG BASE/ML)YesYes
008INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1900MG BASE/190ML (EQ 10MG BASE/ML)YesYes
009INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 2000MG BASE/200ML (EQ 10MG BASE/ML)YesYes
010INFUGEMGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 2200MG BASE/220ML (EQ 10MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-008INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-008INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-008INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-073INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-073INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-073INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-102INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-102INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-102INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-219INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-219INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-219INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-321INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-321INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-321INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-438INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-438INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-438INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-533INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-533INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-533INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-614INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-614INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-614INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-746INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-746INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-746INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-974INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-974INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent
62756-974INFUGEMgemcitabineSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79738SUPPL 2024-09-26
79733SUPPL 2024-09-26
61547SUPPL2020-01-10
61538SUPPL2020-01-09
58300ORIG2019-04-12
54953ORIG2018-10-26
54908ORIG2018-07-17