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Last Updated: May 21, 2022

Details for New Drug Application (NDA): 212038


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NDA 212038 describes ADHANSIA XR, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twelve patents protecting this drug. Additional details are available on the ADHANSIA XR profile page.

The generic ingredient in ADHANSIA XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 212038
Tradename:ADHANSIA XR
Applicant:Purdue Pharma Lp
Ingredient:methylphenidate hydrochloride
Patents:12
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Feb 27, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 28, 2024
Regulatory Exclusivity Use:LABELING REVISIONS RELATED TO CLINICAL STUDIES
Regulatory Exclusivity Expiration:Feb 27, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:See Plans and PricingPatent Expiration:Oct 30, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

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