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Generated: November 15, 2018

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Details for New Drug Application (NDA): 205831

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NDA 205831 describes APTENSIO XR, which is a drug marketed by Rhodes Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the APTENSIO XR profile page.

The generic ingredient in APTENSIO XR 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 205831
Tradename:APTENSIO XR
Applicant:Rhodes Pharms
Ingredient:methylphenidate hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 205831
Suppliers and Packaging for NDA: 205831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 NDA Rhodes Pharmaceuticals L.P. 42858-401 42858-401-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-401-45)
APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 NDA Rhodes Pharmaceuticals L.P. 42858-402 42858-402-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-402-45)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 17, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Dec 16, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Patent:➤ Try a Free TrialPatent Expiration:Dec 16, 2019Product Flag?YSubstance Flag?Delist Request?

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