APPLICATION
ANDA087862
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-18
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2016-11-08Labeling · Supplement 17 · standardAP
2016-03-30Labeling · Supplement 16 · standardAP
2014-06-03Labeling · Supplement 15 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1994-10-11Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1987-12-08Manufacturing (CMC) · Supplement 6AP
1987-04-01Manufacturing (CMC) · Supplement 4AP
1984-11-20Manufacturing (CMC) · Supplement 2AP
1983-04-18OriginalAP
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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