Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204279
Company: HERITAGE PHARMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/20/2014 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
11/18/2016 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-3 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.

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 040808 AMNEAL PHARM
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040804 ECI PHARMS LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040604 EPIC PHARMA LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204279 HERITAGE PHARMA
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 040812 INVAGEN PHARMS
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 207120 NUVO PHARM
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 088617 PLIVA
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040579 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 040808 AMNEAL PHARM
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040804 ECI PHARMS LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040604 EPIC PHARMA LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 204279 HERITAGE PHARMA
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 040812 INVAGEN PHARMS
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 No AB 088618 PLIVA
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040574 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 040808 AMNEAL PHARM
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040804 ECI PHARMS LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040604 EPIC PHARMA LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 204279 HERITAGE PHARMA
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 040812 INVAGEN PHARMS
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 207122 NUVO PHARM
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 088619 PLIVA
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040580 PRINSTON INC

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