APPLICATION
ANDA088593
TYPE
ANDA
ORIGINAL APPROVAL
1984-02-29
LATEST ACTION
1991-01-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDROXYZINE PAMOATEDiscontinued
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL
Approval history
1991-01-23Labeling · Supplement 22AP
1989-11-09Labeling · Supplement 20AP
1989-04-14Labeling · Supplement 15AP
1989-03-27Labeling · Supplement 14AP
1988-09-02Labeling · Supplement 13AP
1984-02-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.