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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208194

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NDA 208194 describes BENDEKA, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BENDEKA profile page.

The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 208194
Tradename:BENDEKA
Applicant:Eagle Pharms
Ingredient:bendamustine hydrochloride
Patents:13
Formulation / Manufacturing:see details
Pharmacology for NDA: 208194
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 208194
Suppliers and Packaging for NDA: 208194
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194 NDA Teva Pharmaceuticals USA, Inc. 63459-348 N 63459-348-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/4ML (25MG/ML)
Approval Date:Dec 7, 2015TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 11, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Patent:➤ Sign UpPatent Expiration:Jan 12, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA
Patent:➤ Sign UpPatent Expiration:Mar 15, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

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