Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/14/1981 | 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 |
|---|---|---|---|---|---|
| 02/16/2021 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2021 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2013 | SUPPL-32 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/20/2002 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/09/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/12/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROXYZINE PAMOATE
CAPSULE;ORAL; EQ 50MG HYDROCHLORIDE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 088487 | BARR |
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 201507 | HERITAGE PHARMA |
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 040156 | IMPAX LABS INC |
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 086183 | SANDOZ |
| VISTARIL | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | Yes | AB | 011459 | PFIZER |