APPLICATION
ANDA085778
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 25MG/ML · INJECTABLE · INJECTION
Approval history
2016-11-08Labeling · Supplement 54 · standardAP
2016-03-30Labeling · Supplement 53 · standardAP
2014-06-03Labeling · Supplement 52 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 50AP
1999-02-02Manufacturing (CMC) · Supplement 49AP
1996-12-04Manufacturing (CMC) · Supplement 48AP
1991-05-23Labeling · Supplement 47AP
1991-01-25Labeling · Supplement 46AP
1989-12-04Labeling · Supplement 44AP
1989-12-04Labeling · Supplement 45AP
1988-11-30Bioequivalence · Supplement 37AP
1988-11-15Manufacturing (CMC) · Supplement 40AP
1988-11-15Manufacturing (CMC) · Supplement 39AP
1986-10-02Manufacturing (CMC) · Supplement 36AP
1983-12-30Manufacturing (CMC) · Supplement 35AP
1982-06-15Manufacturing (CMC) · Supplement 30AP
1982-06-15Manufacturing (CMC) · Supplement 1AP
1982-06-15Manufacturing (CMC) · Supplement 33AP
1982-06-15Manufacturing (CMC) · Supplement 17AP
1982-06-15Manufacturing (CMC) · Supplement 31AP
1982-06-15Manufacturing (CMC) · Supplement 13AP
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.
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