Viewing data from:

VISTARIL

NDA

HYDROXYZINE PAMOATE | N011459 | PFIZER LABORATORIES DIV PFIZER INC

3 strengths0 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 Chain5 active DMFs3 inactive

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

COSMA SPAHYDROXYZINE PAMOATE

DMF 45141982

IPCA LABORATORIES LTDHYDROXYZINE PAMOATE USP

DMF 369542022

SYMED LABS LTDHYDROXYZINE PAMOATE USP

DMF 385352023

EMCURE PHARMACEUTICALS LTDHYDROXYZINE PAMOATE USP

DMF 409772024

COHANCE LIFESCIENCES LTDHYDROXYZINE PAMOATE USP

DMF 427772025

INDUSTRIA CHIMICA PROFARMACO SPAInactiveHYDROXYZINE PAMOATE

DMF 28081976

UCB PHARMACEUTICALS INCInactiveHYDROXYZINE PAMOATE

DMF 36951980

CHEMI SPAInactiveHYDROXYZINE PAMOATE USP. XX

DMF 46291982

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 10, 2016	SUPPL -51	View Letter (PDF)
Feb 22, 2016	SUPPL -50	View Letter (PDF)
Jun 5, 2014	SUPPL -48	View Letter (PDF)
Dec 29, 2004	SUPPL -39	View Letter (PDF)
Mar 21, 2001	SUPPL -36	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — EQ 25MG HYDROCHLORIDE

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#004 — EQ 50MG HYDROCHLORIDE

RLDAB

0 patents0 exclusivities▾

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

#006 — EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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