← FDA DRUG APPROVALS

FDA ANDA · ANDA089031

HYDROXYZINE PAMOATE

Sponsor: SUPERPHARM

APPLICATION
ANDA089031
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-02
LATEST ACTION
1989-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

HYDROXYZINE PAMOATEDiscontinued
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL

Approval history

1989-10-06Labeling · Supplement 7AP
1989-03-16Labeling · Supplement 6AP
1987-01-02OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →