Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021569
Company: LIEBEL-FLARSHEIM
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 | 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 |
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 |