Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040580
Company: PRINSTON INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
05/27/2005 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
11/08/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/04/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/30/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/22/2007 SUPPL-1 Labeling

Label is not available on this site.

HYDROXYZINE HYDROCHLORIDE

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English