Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018894
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLAZAMIDE | TOLAZAMIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| TOLAZAMIDE | TOLAZAMIDE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| TOLAZAMIDE | TOLAZAMIDE | 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 |
|---|---|---|---|---|---|---|---|
| 10/03/1984 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2002 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/18/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/13/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/28/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |