APPLICATION
ANDA085779
TYPE
ANDA
ORIGINAL APPROVAL
1979-10-05
LATEST ACTION
2016-11-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2016-11-08Labeling · Supplement 96 · standardAP
2016-03-30Labeling · Supplement 95 · standardAP
2014-06-03Labeling · Supplement 94 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 92AP
1999-02-02Manufacturing (CMC) · Supplement 91AP
1996-12-04Manufacturing (CMC) · Supplement 90AP
1991-05-23Labeling · Supplement 89AP
1991-02-11Labeling · Supplement 88AP
1990-11-21Manufacturing (CMC) · Supplement 87AP
1989-12-04Labeling · Supplement 86AP
1989-12-04Labeling · Supplement 85AP
1989-08-03Labeling · Supplement 84AP
1988-09-21Bioequivalence · Supplement 82AP
1988-08-03Manufacturing (CMC) · Supplement 80AP
1988-08-03Manufacturing (CMC) · Supplement 81AP
1986-05-28Manufacturing (CMC) · Supplement 76AP
1983-12-30Manufacturing (CMC) · Supplement 75AP
1982-02-08Manufacturing (CMC) · Supplement 73AP
1979-10-05OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.