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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021569
Company: LIEBEL-FLARSHEIM

Products on NDA 021569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	1.125GM/125ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021569PI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021569s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021569s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2018	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021569s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021569Orig1s009ltr.pdf
06/10/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/02/2012	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021569s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021569s004ltr.pdf
10/01/2009	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021569s003lbl.pdf
04/25/2008	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021569s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021569s002ltr.pdf

Labels for NDA 021569

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021569s009lbl.pdf
03/02/2012	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021569s004lbl.pdf
10/01/2009	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021569s003lbl.pdf
04/25/2008	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021569s002lbl.pdf
07/27/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021569PI.pdf

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