Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070159
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLAZAMIDE | TOLAZAMIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/06/1986 | 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 |
|---|---|---|---|---|---|
| 07/08/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/19/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |