Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071529
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIOTHIXENE | THIOTHIXENE | 5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| THIOTHIXENE | THIOTHIXENE | 1MG | CAPSULE;ORAL | Discontinued | None | No | No |
| THIOTHIXENE | THIOTHIXENE | 2MG | CAPSULE;ORAL | Discontinued | None | No | No |
| THIOTHIXENE | THIOTHIXENE | 10MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/24/1987 | 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 |
|---|---|---|---|---|---|
| 11/08/2011 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2010 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 10/30/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/22/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 05/22/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 12/31/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 07/30/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/29/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/06/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/08/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/25/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/25/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 11/08/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/17/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |