Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 09/10/1970 | 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 |
|---|---|---|---|---|---|
| 03/30/2015 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/2013 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/2002 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1985 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/24/1981 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/28/1981 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/03/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/27/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 12/27/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/1977 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/02/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1976 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1974 | SUPPL-3 | Labeling |
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 |