Details for New Drug Application (NDA): 206228

NDA 206228 describes ARSENIC TRIOXIDE, which is a drug marketed by Amneal, Amring Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Nexus, Orbicular, Penn Life, Sandoz, and Zydus Pharms, and is included in eleven NDAs. It is available from fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.

Summary for 206228

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

Suppliers and Packaging for NDA: 206228

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	206228	ANDA	Zydus Lifesciences Limited	49315-005	49315-005-10	10 VIAL in 1 CARTON (49315-005-10) / 10 mL in 1 VIAL (49315-005-01)
ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	206228	ANDA	Zydus Lifesciences Limited	49315-007	49315-007-10	10 VIAL in 1 CARTON (49315-007-10) / 6 mL in 1 VIAL (49315-007-01)

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Aug 30, 2019	TE:	AP	RLD:	No

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