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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209347
Company: EXELA PHARMA

Products on NDA 209347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GANZYK-RTU	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209347Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209347Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2017	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/05/2017	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.
09/20/2017	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209347Orig1s001ltr.pdf

Labels for NDA 209347

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347s001lbl.pdf
09/20/2017	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347s001lbl.pdf
02/17/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209347lbl.pdf

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