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Generated: August 19, 2019

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Details for New Drug Application (NDA): 208861

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NDA 208861 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Barr Labs Inc, Granules Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Wes Pharma Inc, Ascent Pharms Inc, Rising, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Heritage Pharma, Lannett Co Inc, Mylan, Osmotica, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in fifty-three NDAs. It is available from thirty-four 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 208861
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Actavis Elizabeth
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Dec 13, 2018TE:AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Dec 13, 2018TE:AB3RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Dec 13, 2018TE:AB3RLD:No

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