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Details for New Drug Application (NDA): 203585

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NDA 203585 describes SYNRIBO, which is a drug marketed by Ivax Intl 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 SYNRIBO profile page.

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

Summary for NDA: 203585

Ivax Intl
omacetaxine mepesuccinate

Suppliers and Packaging for NDA: 203585

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
omacetaxine mepesuccinate
POWDER;SUBCUTANEOUS 203585 NDA Cephalon, Inc. 63459-177 63459-177-14 1 VIAL, SINGLE-USE in 1 CARTON (63459-177-14) > 1 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:Oct 26, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 26, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 26, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:RE45128Patent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist 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.