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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 02/24/2016 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/2015 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2011 | SUPPL-72 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/14/1993 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1986 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1982 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1981 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1981 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1981 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1981 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1979 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/02/1980 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1979 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1979 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/30/1979 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1979 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1978 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1979 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1979 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1977 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1977 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1977 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1977 | 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. |
||
| 07/13/1976 | 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. |
||
| 08/13/1976 | 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. |
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 | No | AT | 213688 | FRESENIUS KABI USA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 017514 | OTSUKA ICU MEDCL |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018314 | OTSUKA ICU MEDCL |