APPLICATION
ANDA087767
TYPE
ANDA
ORIGINAL APPROVAL
1982-08-16
LATEST ACTION
1996-03-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDROXYZINE PAMOATEDiscontinued
HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE · CAPSULE · ORAL
Approval history
1996-03-18Labeling · Supplement 10AP
1995-02-10Labeling · Supplement 9AP
1994-06-07Labeling · Supplement 8AP
1991-12-27Labeling · Supplement 7AP
1982-08-16OriginalAP
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.