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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210739


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NDA 210739 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 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 210739
Tradename:ARSENIC TRIOXIDE
Applicant:Amneal
Ingredient:arsenic trioxide
Patents:0
Suppliers and Packaging for NDA: 210739
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 210739 ANDA Amneal Pharmaceuticals LLC 70121-1483 70121-1483-7 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1483-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1483-1)
ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 210739 ANDA Amneal Pharmaceuticals LLC 70121-1658 70121-1658-1 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1658-1) / 6 mL in 1 VIAL, SINGLE-DOSE (70121-1658-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Jan 25, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Aug 19, 2021TE:APRLD:No

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