Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
| 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 | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/12/1970 | 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 |
|---|---|---|---|---|---|
| 05/23/2014 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/2015 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/2013 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/2006 | SUPPL-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016733s049ltrs.pdf |
| 07/08/2002 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1981 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/28/1981 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1981 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1980 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/27/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/27/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1978 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/14/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1977 | 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. |
||
| 10/20/1976 | 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. |
||
| 08/30/1974 | SUPPL-3 | Labeling |
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 |