APPLICATION
ANDA087014
TYPE
ANDA
ORIGINAL APPROVAL
1980-06-27
LATEST ACTION
2014-11-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ORGATRAXDiscontinued
HYDROXYZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
ORGATRAXDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2014-11-28Labeling · Supplement 6 · standardAP
2014-06-26Labeling · Supplement 5 · standardAP
1982-07-23Manufacturing (CMC) · Supplement 4AP
1982-07-23Manufacturing (CMC) · Supplement 3AP
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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