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Last Updated: September 18, 2020

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Details for New Drug Application (NDA): 209315

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NDA 209315 describes ARSENIC TRIOXIDE, which is a drug marketed by Amring Pharms, Fresenius Kabi Usa, Ingenus Pharms Llc, Nexus Pharms, Sti Pharma Llc, and Zydus Pharms, and is included in six NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
Summary for 209315
Tradename:ARSENIC TRIOXIDE
Applicant:Ingenus Pharms Llc
Ingredient:arsenic trioxide
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 209315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 209315 ANDA Ingenus Pharmaceuticals, LLC 50742-438 50742-438-10 1 VIAL, GLASS in 1 CARTON (50742-438-10) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 15, 2018TE:APRLD:No

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