Details for New Drug Application (NDA): 021248

✉ Email this page to a colleague

NDA 021248 describes TRISENOX, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. 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. Sixteen 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:	0

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, LLC	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:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 25, 2000	TE:		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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Oct 13, 2017	TE:	AP	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

Expired US Patents for NDA 021248

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	⤷ Sign Up	⤷ Sign Up
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000	⤷ Sign Up	⤷ Sign Up
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	⤷ Sign Up	⤷ Sign Up
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	⤷ Sign Up	⤷ Sign Up
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.