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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040805
Company: HETERO LABS LTD III

Safety Labeling Change Order Letter

Products on ANDA 040805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	AB	No	No
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2008	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
09/26/2017	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/30/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/25/2014	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 040805

HYDROXYZINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	087871	AUROBINDO PHARMA LTD
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040804	CHARTWELL RX
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040604	EPIC PHARMA LLC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	217652	GRAVITI PHARMS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	204279	HERITAGE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040805	HETERO LABS LTD III
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040786	KVK TECH
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040840	NORTHSTAR HLTHCARE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040841	NORTHSTAR HLTHCARE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207121	NUVO PHARMS INC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	088617	PLIVA
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040580	PRINSTON INC

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	087871	AUROBINDO PHARMA LTD
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040804	CHARTWELL RX
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040604	EPIC PHARMA LLC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	217652	GRAVITI PHARMS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	204279	HERITAGE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040805	HETERO LABS LTD III
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040786	KVK TECH
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040840	NORTHSTAR HLTHCARE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040842	NORTHSTAR HLTHCARE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	207121	NUVO PHARMS INC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	Yes	AB	088618	PLIVA
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040580	PRINSTON INC

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	087871	AUROBINDO PHARMA LTD
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040804	CHARTWELL RX
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040604	EPIC PHARMA LLC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	217652	GRAVITI PHARMS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	204279	HERITAGE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040805	HETERO LABS LTD III
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040786	KVK TECH
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040840	NORTHSTAR HLTHCARE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	207121	NUVO PHARMS INC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	088619	PLIVA
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040580	PRINSTON INC

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