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Generated: May 25, 2017

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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. 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 NDA: 208194

Formulation / Manufacturing:see details

Pharmacology for NDA: 208194

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 208194

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bendamustine hydrochloride
SOLUTION;IV (INFUSION) 208194 NDA Teva Pharmaceuticals USA, Inc. 63459-348 63459-348-04 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) > 4 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/4ML (25MG/ML)
Approval Date:Dec 7, 2015TE:RLD:Yes
Patent:8,791,270*PEDPatent Expiration:Jul 12, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:9,265,831Patent Expiration:Jan 28, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:9,572,796Patent Expiration:Jan 28, 2031Product Flag?YSubstance Flag?Delist Request?

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