APPLICATION
ANDA040842
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-31
LATEST ACTION
2014-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2014-06-03Labeling · Supplement 6 · standardAP
2014-04-30Labeling · Supplement 5 · standardAP
2013-01-17Labeling · Supplement 4 · standardAP
2011-12-08Labeling · Supplement 3AP
2008-03-31OriginalAP
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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