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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040156
Company: IMPAX LABS INC

Products on ANDA 040156

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040156

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/1996	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
09/19/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/11/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/27/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/06/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/06/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/31/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040156

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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