← FDA DRUG APPROVALS

FDA ANDA · ANDA217652

HYDROXYZINE HYDROCHLORIDE

Sponsor: GRAVITI PHARMS

APPLICATION
ANDA217652
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-17
LATEST ACTION
2025-04-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

2025-04-22Labeling · Supplement 3 · standardAP
2023-08-17UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →