Details for New Drug Application (NDA): 216117

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

Pharmacology for NDA: 216117

Physiological Effect

Central Nervous System Stimulation

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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	18MG
Approval Date:	Jun 23, 2022	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	27MG
Approval Date:	Jun 23, 2022	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	36MG
Approval Date:	Jun 23, 2022	TE:		RLD:	Yes

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