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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, 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

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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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 verifification 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.

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