Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOLBUTAMIDE | TOLBUTAMIDE | 500MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
07/10/1974 | 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 |
---|---|---|---|---|---|
08/26/1988 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
09/02/1988 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/18/1985 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
06/28/1985 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
09/21/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/1982 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/02/1988 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
12/07/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
09/21/1983 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
12/08/1978 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
12/11/1978 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
05/30/1979 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
05/30/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
05/30/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
05/30/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
01/23/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |