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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 203583

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NDA 203583 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 203583

Tradename:	METHYLPHENIDATE HYDROCHLORIDE
Applicant:	Specgx Llc
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 203583

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 203583

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	203583	ANDA	SpecGx LLC	0406-1810	0406-1810-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1810-01)
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	203583	ANDA	SpecGx LLC	0406-1820	0406-1820-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1820-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Sep 29, 2015	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Sep 29, 2015	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Sep 29, 2015	TE:	AB2	RLD:	No

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