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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208313
Company: SUN PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
INFUGEM GEMCITABINE HYDROCHLORIDE EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208313Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208313Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208313Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208313s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208313Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/08/2020 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208313s002lbl.pdf
07/16/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208313Orig1s000lbl.pdf
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