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Details for New Drug Application (NDA): 206256

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NDA 206256 describes BELEODAQ, which is a drug marketed by Spectrum Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BELEODAQ profile page.

The generic ingredient in BELEODAQ is belinostat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the belinostat profile page.

Summary for NDA: 206256

Tradename:
BELEODAQ
Applicant:
Spectrum Pharms
Ingredient:
belinostat
Patents:2

Pharmacology for NDA: 206256

Suppliers and Packaging for NDA: 206256

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELEODAQ
belinostat
POWDER;IV (INFUSION) 206256 NDA Spectrum Pharmaceuticals, Inc. 68152-108 68152-108-09 1 VIAL, SINGLE-USE in 1 CARTON (68152-108-09) > 10 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength500MG/VIAL
Approval Date:Jul 3, 2014TE:RLD:Yes
Patent:8,835,501Patent Expiration:Oct 27, 2027Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jul 3, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 3, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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