Last Updated: October 5, 2026

Details for New Drug Application (NDA): 207416

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NDA 207416 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, 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, 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 suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 207416

Tradename:	METHYLPHENIDATE HYDROCHLORIDE
Applicant:	Ascent Pharms Inc
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 207416

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 207416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	207416	ANDA	Camber Pharmaceutical Inc	31722-173	31722-173-01	100 TABLET in 1 BOTTLE (31722-173-01)
METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	207416	ANDA	Camber Pharmaceutical Inc	31722-173	31722-173-05	500 TABLET in 1 BOTTLE (31722-173-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 22, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 22, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 22, 2015	TE:	AB	RLD:	No

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