Drugs@FDA: FDA-Approved Drugs
Company: ANIMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 07/17/1980 | 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-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2003 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-31 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/17/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1992 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1990 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |