Details for New Drug Application (NDA): 217413

NDA 217413 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 217413

Tradename:	ARSENIC TRIOXIDE
Applicant:	Orbicular
Ingredient:	arsenic trioxide
Patents:	0

Suppliers and Packaging for NDA: 217413

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	217413	ANDA	Novadoz Pharmaceuticals LLC	72205-171	72205-171-07	10 VIAL, SINGLE-DOSE in 1 CARTON (72205-171-07) / 10 mL in 1 VIAL, SINGLE-DOSE (72205-171-01)
ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	217413	ANDA	Novadoz Pharmaceuticals LLC	72205-172	72205-172-07	10 VIAL, SINGLE-DOSE in 1 CARTON (72205-172-07) / 6 mL in 1 VIAL, SINGLE-DOSE (72205-172-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Apr 20, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Apr 20, 2023	TE:	AP	RLD:	No

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