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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 208313

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208313

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/24/2024	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208313s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208313Orig1s007ltr.pdf
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

Labels for NDA 208313

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/24/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208313s007lbl.pdf
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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