Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019217
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Discontinued 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
07/13/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/01/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1998 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/05/2003 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19217slr003ltr.pdf
03/25/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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