Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
02/02/1979 | 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 |
---|---|---|---|---|---|
07/24/2024 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016677s185,016682s124,018016s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016677Orig1s185,016682Orig1s124,018016Orig1s071ltr.pdf | |
05/29/2019 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016677s169,018016s067,020178s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016677Orig1s169, 018016Orig1s067, 020178Orig1s021ltr.pdf | |
12/22/2014 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf | |
09/11/2013 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf | |
08/26/2005 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf | |
05/23/2005 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018016s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018016s056ltr.pdf | |
07/17/2003 | SUPPL-53 | Manufacturing (CMC)-Packaging, Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18016scp053ltr.pdf |
08/14/2001 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/24/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/2002 | SUPPL-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf |
04/29/1997 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/18/1994 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1994 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/29/1991 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/26/1991 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/24/1990 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/15/1991 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/1989 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/25/1987 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/28/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/27/1986 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/15/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/18/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
06/13/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/22/1984 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/28/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1985 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/16/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/24/1985 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/22/1982 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/11/1983 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
11/20/1981 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/03/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/1982 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/26/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
12/21/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/29/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/21/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/31/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/18/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/30/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/07/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/02/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/28/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/25/1980 | 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 |
---|---|---|---|---|---|
07/24/2024 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016677s185,016682s124,018016s071lbl.pdf | |
05/29/2019 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016677s169,018016s067,020178s021lbl.pdf | |
12/22/2014 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf | |
09/11/2013 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf | |
08/26/2005 | SUPPL-57 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf | |
05/23/2005 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018016s056lbl.pdf |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 450MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019635 | B BRAUN |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018016 | BAXTER HLTHCARE |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 208122 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019759 | HOSPIRA |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018090 | ICU MEDICAL INC |