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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

Spectrum Pharms

Pharmacology for NDA: 206256

Suppliers and Packaging for NDA: 206256

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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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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.