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HYDROXYZINE HYDROCHLORIDE

ANDA

HYDROXYZINE HYDROCHLORIDE | A220271 | SAPTALIS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs2 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

COSMA SPAHYDROXYZINE HYDROCHLORIDE

DMF 44351982

SYMED LABS LTDHYDROXYZINE HYDROCHLORIDE

DMF 195962006

IPCA LABORATORIES LTDHYDROXYZINE HYDROCHLORIDE USP

DMF 232832010

CALYX CHEMICALS AND PHARMACEUTICALS LTDHYDROXYZINE HYDROCHLORIDE

DMF 240022010

SRIKEM LABORATORIES PVT LTDHYDROXYZINE HYDROCHLORIDE USP

DMF 283762014

CHEMISCHE FABRIK BERG GMBHHYDROXYZINE HYDROCHLORIDE

DMF 352492023

GLOCHEM INDUSTRIES PRIVATE LTDHYDROXYZINE HYDROCHLORIDE

DMF 371182022

FLEMING LABORATORIES LTDHYDROXYZINE HYDROCHLORIDE USP

DMF 382732023

MAHI DRUGS PRIVATE LTDHYDROXYZINE HYDROCHLORIDE USP

DMF 391592023

EMCURE PHARMACEUTICALS LTDHYDROXYZINE HYDROCHLORIDE USP

DMF 395392024

UCB SA PHARMACEUTIQUE SECTEURInactiveHYDROXYZINE HYDROCHLORIDE COMPACTED

DMF 138521998

AARTI DRUGS LTDInactiveHYDROXYZINE HYDROCHLORIDE

DMF 220422008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 10MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Jun 11, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Saptalis Pharma added hydroxyzine hydrochloride (NDA 220271, supplement 001) to the FDA drug product database.

New: New record