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Generated: October 23, 2018

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Details for New Drug Application (NDA): 200886

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NDA 200886 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Barr Labs Inc, 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, Anda Repository, Ascent Pharms Inc, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Ani Pharms Inc, Cnty Line Pharms, Lannett Co Inc, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Bionpharma Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in forty-five NDAs. It is available from twenty-nine 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 200886
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Mayne Pharma
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200886
Suppliers and Packaging for NDA: 200886
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 200886 ANDA Mayne Pharma 51862-262 51862-262-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-262-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Feb 26, 2018TE:AB1RLD:No

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