Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201507
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

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