APPLICATION
ANDA040580
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-27
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2016-11-08Labeling · Supplement 14 · standardAP
2016-03-30Labeling · Supplement 11 · standardAP
2014-06-04Labeling · Supplement 8 · standardAP
2013-04-30Labeling · Supplement 5 · standardAP
2007-03-22Labeling · Supplement 1AP
2005-05-27OriginalAP
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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