Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070259
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 11/07/1986 | 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 |
|---|---|---|---|---|---|
| 03/10/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/20/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 01/10/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 03/10/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/20/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/15/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/26/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 02/05/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/21/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |