Details for New Drug Application (NDA): 022249

NDA 022249 describes TREANDA, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TREANDA profile page.

The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for 022249

Tradename:	TREANDA
Applicant:	Cephalon
Ingredient:	bendamustine hydrochloride
Patents:	9
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022249

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 022249

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 022249

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249	NDA	Cephalon, LLC	63459-390	63459-390-08	1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE
TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249	NDA	Cephalon, LLC	63459-390	63459-390-08	1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;IV (INFUSION)			Strength	100MG/VIAL
Approval Date:	Mar 20, 2008	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 7, 2022
Regulatory Exclusivity Use:	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Patent:		Patent Expiration:	Apr 26, 2031	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:		Patent Expiration:	Sep 26, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

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