Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088942
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE INTENSOL | 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 |
|---|---|---|---|---|---|---|---|
| 12/16/1985 | 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 |
|---|---|---|---|---|---|
| 11/26/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/02/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/21/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/21/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1989 | SUPPL-1 | Bioequivalence |
Label is not available on this site. |