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 | 25MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 10/05/1979 | 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-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2014 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-50 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-49 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-48 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/23/1991 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 01/25/1991 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 12/04/1989 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/04/1989 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 11/15/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1988 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1988 | SUPPL-37 | Bioequivalence |
Label is not available on this site. |
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| 10/02/1986 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1983 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/15/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |