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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 six 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. There is one tentative approval for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for NDA: 208194

Eagle Pharms
bendamustine hydrochloride
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:8,609,707Patent Expiration:Aug 11, 2031Product Flag?YSubstance Flag?Delist Request?

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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.