Drugs@FDA: FDA-Approved Drugs
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14.6% | SODIUM CHLORIDE | 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |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 | AP | 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. |
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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%
SOLUTION;INTRAVENOUS; 400MEQ/100ML (4MEQ/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212070 | FRESENIUS KABI USA |
SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 400MEQ/100ML (4MEQ/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 018897 | HOSPIRA |