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Details for 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 seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TREANDA profile page.

The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is 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:7
Suppliers: see list1

Pharmacology for NDA: 022249

Mechanism of ActionAlkylating Activity
Glossary

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength100MG/VIAL
Approval Date:Mar 20, 2008TE:RLD:Yes
Patent:8,791,270Patent Expiration:Jan 12, 2026Product Flag?YSubstance Flag?Delist Request?
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


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