APPLICATION
ANDA086821
TYPE
ANDA
ORIGINAL APPROVAL
1979-09-05
LATEST ACTION
1998-05-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
1998-05-05Manufacturing (CMC) · Supplement 13AP
1997-01-16Manufacturing (CMC) · Supplement 11AP
1996-10-03Manufacturing (CMC) · Supplement 12AP
1982-05-24Manufacturing (CMC) · Supplement 7AP
1982-05-24Manufacturing (CMC) · Supplement 8AP
1979-09-05OriginalAP
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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