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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 206228


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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 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 206228
Tradename:ARSENIC TRIOXIDE
Applicant:Zydus Pharms
Ingredient:arsenic trioxide
Patents:0
Formulation / Manufacturing:see details
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:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 13, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Aug 30, 2019TE:APRLD:No

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