APPLICATION
ANDA088184
TYPE
ANDA
ORIGINAL APPROVAL
1983-03-31
LATEST ACTION
2007-05-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
Approval history
2007-05-21Manufacturing (CMC) · Supplement 6AP
1991-05-29Labeling · Supplement 5AP
1990-10-05Manufacturing (CMC) · Supplement 3AP
1990-10-05Manufacturing (CMC) · Supplement 4AP
1988-06-03Manufacturing (CMC) · Supplement 2AP
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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