Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| 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 |
|---|---|---|---|---|---|---|---|
| 04/04/1979 | 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 |
|---|---|---|---|---|---|
| 09/21/2017 | SUPPL-116 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018090sS116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018090Orig1s116ltr.pdf | |
| 09/08/2014 | SUPPL-114 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/2014 | SUPPL-105 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2007 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 04/16/2017 | SUPPL-86 |
Label is not available on this site. |
|||
| 11/01/2002 | SUPPL-81 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/25/2001 | SUPPL-80 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1998 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-75 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/018090s075lbl.pdf | |
| 08/06/1996 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1986 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1983 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1981 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1981 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1980 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1980 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1980 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1979 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1979 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1980 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/06/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1979 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1979 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/21/2017 | SUPPL-116 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018090sS116lbl.pdf | |
| 07/02/1999 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/018090s075lbl.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 |