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Last Updated: May 26, 2022

Details for New Drug Application (NDA): 205489


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NDA 205489 describes COTEMPLA XR-ODT, which is a drug marketed by Neos Theraps Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the COTEMPLA XR-ODT profile page.

The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
Summary for 205489
Tradename:COTEMPLA XR-ODT
Applicant:Neos Theraps Inc
Ingredient:methylphenidate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 205489
Medical Subject Heading (MeSH) Categories for 205489
Suppliers and Packaging for NDA: 205489
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NDA Neos Therapeutics Brands, LLC 70165-100 70165-100-30 5 BLISTER PACK in 1 CARTON (70165-100-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NDA Neos Therapeutics Brands, LLC 70165-200 70165-200-30 5 BLISTER PACK in 1 CARTON (70165-200-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrength8.6MG
Approval Date:Jun 19, 2017TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jan 25, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
Patent:See Plans and PricingPatent Expiration:Jun 5, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

McKinsey
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Merck
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Harvard Business School
McKesson

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