Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088564
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 05/11/1984 | 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 |
|---|---|---|---|---|---|
| 02/24/2017 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/17/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/31/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/05/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 07/05/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/22/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 06/09/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/15/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/26/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/26/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |