Viewing data from:

PHENOXYBENZAMINE HYDROCHLORIDE

ANDA

PHENOXYBENZAMINE HYDROCHLORIDE | A204522 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2019-P-1607 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act on April 2, 2019, requesting that the FDA designate an alternative reference standard for in vivo bioequivalence studies to support its ANDA application for Phenoxybenzamine Hydroc	505(q)	2019-04-04	Denied	Aurobindo Pharma USA

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain5 active DMFs1 inactive

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

MATRIX PHARMACORP PRIVATE LTDPHENOXYBENZAMINE HYDROCHLORIDE USP

DMF 200112006

PH HEALTH LTDPHENOXYBENZAMINE HYDROCHLORIDE USP

DMF 255802012

NAVINTA LLCPHENOXYBENZAMINE HYDROCHLORIDE USP

DMF 317462017

SS PHARMA LLCPHENOXYBENZAMINE HYDROCHLORIDE USP

DMF 324432018

APITORIA PHARMA PRIVATE LTDPHENOXYBENZAMINE HYDROCHLORIDE USP

DMF 334772018

ISP CHEMICALS INCInactivePHENOXYBENZAMINE HYDROCHLORIDE (PBZA)

DMF 165932003

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 30, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 24, 2017

No patent or exclusivity listings for this strength.