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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 210924

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NDA 210924 describes METHYLPHENIDATE, which is a drug marketed by Mylan Tech Viatris, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in seventy-one NDAs. It is available from one supplier. Additional details are available on the METHYLPHENIDATE profile page.

The generic ingredient in METHYLPHENIDATE 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 210924

Tradename:	METHYLPHENIDATE
Applicant:	Actavis Elizabeth
Ingredient:	methylphenidate
Patents:	0

Medical Subject Heading (MeSH) Categories for 210924

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL			Strength	8.6MG
Approval Date:	Jun 19, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL			Strength	17.3MG
Approval Date:	Jun 19, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL			Strength	25.9MG
Approval Date:	Jun 19, 2020	TE:		RLD:	No

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