Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | None | No | Yes |
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | None | No | No |
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | None | No | No |
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1983 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 12/03/2010 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 06/12/2009 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 01/23/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 04/25/2008 | SUPPL-31 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 09/05/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 08/14/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/17/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/31/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/30/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 01/04/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 03/29/1989 | SUPPL-15 | Bioequivalence |
Label is not available on this site. |
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| 12/20/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/20/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/20/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/06/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/20/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/10/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |