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Generated: November 21, 2018

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. It is available from one supplier. There are two 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. Ten 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 205525
Ingredient-typeCannabinoids
Medical Subject Heading (MeSH) Categories for 205525
Suppliers and Packaging for NDA: 205525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNDROS dronabinol SOLUTION;ORAL 205525 NDA Insys Therapeutics, Inc. 20482-335 20482-335-30 1 BOTTLE, GLASS in 1 CARTON (20482-335-30) > 30 mL in 1 BOTTLE, GLASS

Profile for product number 001

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

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