Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE 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 |
|---|---|---|---|---|---|---|---|
| 09/15/1983 | 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 |
|---|---|---|---|---|---|
| 11/08/2016 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2014 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/04/2002 | SUPPL-30 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/26/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/2002 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/21/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/30/1988 | SUPPL-13 | Bioequivalence |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |