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 | 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 |
|---|---|---|---|---|---|---|---|
| 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-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2014 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/26/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/23/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/21/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/30/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/30/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |