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ARSENIC TRIOXIDE

ANDA

ARSENIC TRIOXIDE | A208231 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TRISENOX(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Cephalon, Inc. et al v. Fresenius Kabi USA, LLC 1:2015cv01074 4 patentsANDA 208231arsenic trioxide	D. Del.	2015-11-19	Terminated 2016-08-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain5 active DMFs2 inactive

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

HERAEUS PRECIOUS METALS GMBH AND CO KGARSENIC TRIOXIDE USP

DMF 200332006

CHEMWERTH INCARSENIC TRIOXIDE

DMF 260752012

UMICORE ARGENTINA SAARSENIC TRIOXIDE

DMF 313252017

EMCURE PHARMACEUTICALS LTDARSENIC TRIOXIDE

DMF 334532019

CHEMCON GMBHARSENIC TRIOXIDE

DMF 337582019

TTY BIOPHARM CO LTDInactiveArsenic Trioxide

DMF 210922007

CADILA HEALTHCARE LTDInactiveARSENIC TRIOXIDE

DMF 273822013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 7, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 31, 2018

No patent or exclusivity listings for this strength.