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Details for New Drug Application (NDA): 022249

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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 eight 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-two drug master file entries for this compound. Two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for NDA: 022249

Tradename:
TREANDA
Applicant:
Cephalon
Ingredient:
bendamustine hydrochloride
Patents:8
Formulation / Manufacturing:see details

Pharmacology for NDA: 022249

Mechanism of ActionAlkylating Activity

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, Incorporated 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
POWDER;IV (INFUSION) 022249 NDA Cephalon, Incorporated 63459-391 63459-391-20 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-391-20) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength100MG/VIAL
Approval Date:Mar 20, 2008TE:APRLD:Yes
Patent:8,436,190*PEDPatent Expiration:Apr 26, 2031Product Flag?Substance Flag?Delist Request?Y
Patent:8,445,524*PEDPatent Expiration:Sep 26, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:8,609,863*PEDPatent Expiration:Jul 12, 2026Product Flag?Substance Flag?Delist Request?Y


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