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Generated: November 15, 2018

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Details for New Drug Application (NDA): 209311

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NDA 209311 describes JORNAY PM, which is a drug marketed by Ironshore Pharms and is included in one NDA. There are eight patents protecting this drug. Additional details are available on the JORNAY PM profile page.

The generic ingredient in JORNAY PM is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 209311
Tradename:JORNAY PM
Applicant:Ironshore Pharms
Ingredient:methylphenidate hydrochloride
Patents:8
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Aug 8, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 8, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Mar 23, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Patent:➤ Try a Free TrialPatent Expiration:Mar 23, 2032Product Flag?YSubstance Flag?Delist Request?

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