Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089953
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/07/1988 | 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-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2002 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |