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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 210802

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NDA 210802 describes ARSENIC TRIOXIDE, which is a drug marketed by Amneal, Amring Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland, MSN, Nexus, Novast Labs, Penn Life, Sandoz, and Zydus Pharms, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the ARSENIC TRIOXIDE profile page.

The generic ingredient in ARSENIC TRIOXIDE is arsenic trioxide. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.

Summary for 210802

Tradename:	ARSENIC TRIOXIDE
Applicant:	Amring Pharms
Ingredient:	arsenic trioxide
Patents:	0

Suppliers and Packaging for NDA: 210802

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	210802	ANDA	Nordic Pharma, Inc.	69918-720	69918-720-10	10 VIAL, GLASS in 1 CARTON (69918-720-10) / 10 mL in 1 VIAL, GLASS (69918-720-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Nov 13, 2018	TE:	AP	RLD:	No

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