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FDA ANDA · ANDA088350

HYDROXYZINE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA088350
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-15
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2016-11-08Labeling · Supplement 47 · standardAP
2016-03-30Labeling · Supplement 46 · standardAP
2014-12-31Labeling · Supplement 45 · standardAP
2002-01-30Labeling · Supplement 23AP
2001-11-26Manufacturing (CMC) · Supplement 24AP
1998-03-23Manufacturing (CMC) · Supplement 18AP
1993-01-29Manufacturing (CMC) · Supplement 17AP
1992-01-30Manufacturing (CMC) · Supplement 8AP
1992-01-30Manufacturing (CMC) · Supplement 13AP
1992-01-30Manufacturing (CMC) · Supplement 9AP
1992-01-30Manufacturing (CMC) · Supplement 12AP
1991-08-07Manufacturing (CMC) · Supplement 15AP
1990-11-19Manufacturing (CMC) · Supplement 16AP
1990-06-29Manufacturing (CMC) · Supplement 14AP
1989-02-14Labeling · Supplement 11AP
1988-11-21Labeling · Supplement 10AP
1986-02-12Manufacturing (CMC) · Supplement 4AP
1985-02-15Manufacturing (CMC) · Supplement 2AP
1985-02-15Manufacturing (CMC) · Supplement 3AP
1984-09-20Manufacturing (CMC) · Supplement 1AP
1983-09-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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