Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201507
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | No | No |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/03/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/24/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
07/11/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
HYDROXYZINE PAMOATE
CAPSULE;ORAL; EQ 25MG 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 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 088496 | BARR |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 201507 | HERITAGE PHARMA |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 040156 | IMPAX LABS INC |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 087479 | SANDOZ |
VISTARIL | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | Yes | AB | 011459 | PFIZER |
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 |