Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| 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 |
|---|---|---|---|---|---|---|---|
| 05/30/1980 | 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 |
|---|---|---|---|---|---|
| 08/29/2001 | SUPPL-48 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1993 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1991 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1985 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1985 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1982 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/03/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1982 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1981 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-1 | 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 |