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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 040321


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NDA 040321 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, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Patrin, 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 sixty-nine NDAs. It is available from thirty-five 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 040321
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Actavis Elizabeth
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Feb 5, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Feb 5, 2002TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Feb 5, 2002TE:RLD:No

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