APPLICATION
ANDA087546
TYPE
ANDA
ORIGINAL APPROVAL
1981-06-15
LATEST ACTION
2001-02-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2001-02-14Manufacturing (CMC) · Supplement 10AP
1995-12-22Manufacturing (CMC) · Supplement 9AP
1991-07-19Labeling · Supplement 7AP
1989-12-26Manufacturing (CMC) · Supplement 4AP
1989-12-26Manufacturing (CMC) · Supplement 5AP
1989-09-12Labeling · Supplement 6AP
1989-07-31Labeling · Supplement 3AP
1981-06-15OriginalAP
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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