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 | No | 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 |
|---|---|---|---|---|---|---|---|
| 02/22/1980 | 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 |
|---|---|---|---|---|---|
| 02/07/2011 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/06/2004 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 08/21/1997 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1997 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1996 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1984 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1981 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1980 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/03/1980 | SUPPL-1 | Labeling |
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 |