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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209445
Company: SHIONOGI INC

Products on NDA 209445

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FETROJA	CEFIDEROCOL SULFATE TOSYLATE	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209445Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2021	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209445s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209445Orig1s004ltr.pdf
09/25/2020	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209445s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209445Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209445Orig1s002.pdf

Labels for NDA 209445

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209445s004lbl.pdf
11/12/2021	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209445s004lbl.pdf
09/25/2020	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209445s002lbl.pdf
11/14/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf

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