Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021569
Company: LIEBEL-FLARSHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 405MG/50ML (9MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 1012.5MG/125ML (9MG/ML) INJECTABLE;INJECTION Prescription None Yes No
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
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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