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Generated: May 1, 2017

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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 and one Paragraph IV challenge. Additional details are available on the SYNRIBO profile page.

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

Summary for NDA: 203585


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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