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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 216117


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NDA 216117 describes RELEXXII, which is a drug marketed by Osmotica Pharm Us and is included in one NDA. It is available from two suppliers. Additional details are available on the RELEXXII profile page.

The generic ingredient in RELEXXII is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 216117
Tradename:RELEXXII
Applicant:Osmotica Pharm Us
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 216117
Suppliers and Packaging for NDA: 216117
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RELEXXII methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 216117 NDA Trigen Laboratories, LLC 13811-700 13811-700-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30)
RELEXXII methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 216117 NDA Trigen Laboratories, LLC 13811-711 13811-711-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-711-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength18MG
Approval Date:Jun 23, 2022TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength27MG
Approval Date:Jun 23, 2022TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength36MG
Approval Date:Jun 23, 2022TE:RLD:Yes

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