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Generated: November 19, 2018

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Details for New Drug Application (NDA): 021248

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NDA 021248 describes TRISENOX, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRISENOX profile page.

The generic ingredient in TRISENOX is arsenic trioxide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
Summary for 021248
Tradename:TRISENOX
Applicant:Cephalon
Ingredient:arsenic trioxide
Patents:6
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021248
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248 NDA Cephalon, Inc. 63459-600 63459-600-10 10 AMPULE in 1 CARTON (63459-600-10) > 10 mL in 1 AMPULE (63459-600-01)
TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248 NDA Cephalon, Inc. 63459-601 63459-601-06 10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) > 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Sep 25, 2000TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 12, 2025
Regulatory Exclusivity Use:ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION
Patent:➤ Try a Free TrialPatent Expiration:Nov 10, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:IN COMBINATION WITH TRETINOIN, TREATING ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-A GENE EXPRESSION
Patent:➤ Try a Free TrialPatent Expiration:Nov 10, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHO ARE REFRACTORY TO, OR HAVE RELAPSED FROM, RETINOID AND ANTHRACYCLINE CHEMOTHERAPY, AND WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION

Expired US Patents for NDA 021248

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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