Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018897
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
SODIUM CHLORIDE 23.4% SODIUM CHLORIDE 400MEQ/100ML (4MEQ/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/1984 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
06/12/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/18/2020 SUPPL-24 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018897Orig1s024lbl.pdf
03/14/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18897s16ltr.pdf
02/16/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1999 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/2000 SUPPL-13 Labeling

Label is not available on this site.

01/13/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-11 Labeling

Label is not available on this site.

08/29/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1992 SUPPL-7 Labeling

Label is not available on this site.

10/21/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1986 SUPPL-3 Labeling

Label is not available on this site.

09/04/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/18/2020 SUPPL-24 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018897Orig1s024lbl.pdf

SODIUM CHLORIDE 14.6%

SOLUTION;INTRAVENOUS; 100MEQ/40ML (2.5MEQ/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS Prescription No AP 212070 FRESENIUS KABI USA
SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 018897 HOSPIRA

SODIUM CHLORIDE 23.4%

There are no Therapeutic Equivalents.

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