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NDA

HYDROXYZINE HYDROCHLORIDE | N010485 | ROERIG DIV PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 21, 2001	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.