Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESECTISOL IN PLASTIC CONTAINER | MANNITOL | 5GM/100ML | SOLUTION;IRRIGATION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/10/1978 | 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 |
|---|---|---|---|---|---|
| 11/16/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2003 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/11/1990 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1985 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1980 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/28/1978 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1978 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |