Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STERILE WATER | STERILE WATER FOR IRRIGATION | 100% | LIQUID;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 |
|---|---|---|---|---|---|---|---|
| 12/31/1974 | 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 |
|---|---|---|---|---|---|
| 08/04/2016 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2017 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017428s071_017866s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017428Orig1s071,017866Orig1s052ltr.pdf | |
| 09/28/2011 | SUPPL-69 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/14/1993 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1986 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1985 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1982 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1981 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1981 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1981 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1981 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/09/1982 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 04/09/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1982 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/09/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1979 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1980 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/02/1980 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1979 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1979 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/14/1979 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1979 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1978 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1979 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1979 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1977 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1977 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1979 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1977 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1976 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1976 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1976 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1976 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1976 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1976 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/02/1976 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1976 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1976 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1975 | 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 |
|---|---|---|---|---|---|
| 10/17/2017 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017428s071_017866s052lbl.pdf |
STERILE WATER
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 |