Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088479
Company: HERITAGE PHARMA AVET
Company: HERITAGE PHARMA AVET
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/08/1983 | 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-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/09/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1989 | SUPPL-10 | Bioequivalence |
Label is not available on this site. |
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| 08/10/1989 | SUPPL-9 | Bioequivalence |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/15/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |