Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088229
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 100MG/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 08/23/1983 | 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-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/24/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/26/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 11/20/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/23/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/25/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/31/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/03/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |