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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209604
Company: ACCORD HLTHCARE

Products on NDA 209604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209604s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209604Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209604Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209604s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209604Orig1s004ltr.pdf
07/30/2018	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604s003ltr.pdf
12/18/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604Orig1s002ltr.pdf

Labels for NDA 209604

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209604s004lbl.pdf
12/18/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s002lbl.pdf
07/30/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s003lbl.pdf
08/03/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209604s000lbl.pdf

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