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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204115

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NDA 204115 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by 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, Chartwell Molecular, Hibrow Hlthcare, Novel Labs Inc, Novitium Pharma, Quagen, Tris Pharma Inc, Rising, Strides Pharma, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma Intl, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Mpp Pharma, Oxford Pharms, and Prinston Inc, and is included in sixty-nine NDAs. It is available from thirty-six suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE 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 204115

Tradename:	METHYLPHENIDATE HYDROCHLORIDE
Applicant:	Novel Labs Inc
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 204115

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 204115

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	204115	ANDA	Lupin Pharmaceuticals,Inc.	43386-570	43386-570-01	100 TABLET, CHEWABLE in 1 BOTTLE (43386-570-01)
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	204115	ANDA	Lupin Pharmaceuticals,Inc.	43386-571	43386-571-01	100 TABLET, CHEWABLE in 1 BOTTLE (43386-571-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	2.5MG
Approval Date:	Feb 25, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	5MG
Approval Date:	Feb 25, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	10MG
Approval Date:	Feb 25, 2015	TE:		RLD:	No

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