APPLICATION
ANDA089381
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-19
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2016-11-08Labeling · Supplement 35 · standardAP
2016-03-30Labeling · Supplement 34 · standardAP
2014-06-03Labeling · Supplement 30 · standardAP
2006-07-21Labeling · Supplement 23AP
2002-04-03Manufacturing (CMC) · Supplement 11AP
2002-03-12Labeling · Supplement 12AP
2002-03-05Manufacturing (CMC) · Supplement 10AP
2001-02-26Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 7AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-02-24Manufacturing (CMC) · Supplement 5AP
1995-06-22Manufacturing (CMC) · Supplement 4AP
1994-01-12Manufacturing (CMC) · Supplement 3AP
1990-10-09Manufacturing (CMC) · Supplement 2AP
1989-12-04Labeling · Supplement 1AP
1986-05-19OriginalAP
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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