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Last Updated: June 8, 2023

Details for New Drug Application (NDA): 205580


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NDA 205580 describes BELRAPZO, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the BELRAPZO profile page.

The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 205580
Tradename:BELRAPZO
Applicant:Eagle Pharms
Ingredient:bendamustine hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 205580
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 205580
Suppliers and Packaging for NDA: 205580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580 NDA Eagle Pharmaceuticals, Inc 42367-521 42367-521-25 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 1 INJECTION in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/4ML (25MG/ML)
Approval Date:May 15, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 7, 2022
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Patent:⤷  Try a TrialPatent Expiration:Jan 28, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jan 28, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

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Serving leading biopharmaceutical companies globally:

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