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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206473
Company: HOSPIRA

Products on NDA 206473

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206473s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206473Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206473Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206473s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206473Orig1s007ltr.pdf
01/18/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206473s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206473Orig1s005ltr.pdf
08/12/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206473s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206473Orig1s004ltr.pdf
07/29/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206473s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206473Orig1s003ltr.pdf
08/22/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206473s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206473Orig1s002Ltr.pdf
12/15/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206473s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206473Orig1s001ltr.pdf

Labels for NDA 206473

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206473s007lbl.pdf
01/18/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206473s005lbl.pdf
08/12/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206473s004lbl.pdf
07/29/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206473s003lbl.pdf
08/22/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206473s002lbl.pdf
12/15/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206473s001lbl.pdf
06/18/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206473s000lbl.pdf

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