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Generated: April 26, 2019

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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 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. Three 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 ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 022249
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, Inc. 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, Inc. 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:RXDosage:POWDER;IV (INFUSION)Strength100MG/VIAL
Approval Date:Mar 20, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 26, 2031Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Sep 26, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jul 12, 2026Product Flag?Substance Flag?Delist Request?Y

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