APPLICATION
ANDA040899
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-10
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2016-11-08Labeling · Supplement 5 · standardAP
2016-03-30Labeling · Supplement 4 · standardAP
2014-06-03Labeling · Supplement 3 · standardAP
2008-06-10OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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