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 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 04/08/1974 | 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-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/2004 | SUPPL-58 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17514slr058ltr.pdf |
| 02/10/1998 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1988 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1986 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1986 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1984 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1986 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1984 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1981 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/25/1980 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1980 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1981 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1980 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1980 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1979 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1979 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1979 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/03/1979 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/01/1979 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1978 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1978 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1977 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1977 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/29/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/07/1975 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1975 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1975 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SOLUTION;IRRIGATION; 900MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 016733 | B BRAUN |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 017427 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 017867 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 017514 | ICU MEDICAL INC |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018314 | ICU MEDICAL INC |