Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 09/24/2014 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1998 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1988 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1986 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1986 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1984 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1984 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1981 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 08/26/1982 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/01/1980 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/06/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1981 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1980 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1979 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1979 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1979 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/03/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/01/1979 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1978 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1978 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/22/1977 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1977 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/29/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/07/1975 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1975 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1975 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
STERILE WATER IN PLASTIC CONTAINER
LIQUID;IRRIGATION; 100%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;IRRIGATION | Prescription | Yes | AT | 017428 | BAXTER HLTHCARE |
| STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;IRRIGATION | Prescription | Yes | AT | 016734 | B BRAUN |
| STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;IRRIGATION | Prescription | No | AT | 017866 | BAXTER HLTHCARE |
| STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;IRRIGATION | Prescription | No | AT | 017513 | ICU MEDICAL INC |
| STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;IRRIGATION | Prescription | No | AT | 018313 | ICU MEDICAL INC |