Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089382
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/19/1986 | 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-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |