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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205525

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NDA 205525 describes SYNDROS, which is a drug marketed by Insys Dev Co Inc and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SYNDROS profile page.

The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dronabinol profile page.
Summary for 205525
Tradename:SYNDROS
Applicant:Insys Dev Co Inc
Ingredient:dronabinol
Patents:3
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205525

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML
Approval Date:Mar 23, 2017TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 6, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Aug 6, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Aug 6, 2028Product Flag?YSubstance Flag?YDelist Request?

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