APPLICATION
ANDA040804
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2016-11-08Labeling · Supplement 5 · standardAP
2016-03-30Labeling · Supplement 4 · standardAP
2014-12-23Labeling · Supplement 3 · standardAP
2008-06-30OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.