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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206497


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NDA 206497 describes METHYLPHENIDATE, which is a drug marketed by Mylan Tech Viatris, 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, Breckenridge, Chartwell Molecular, Novel Labs Inc, 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 seventy-one NDAs. It is available from one supplier. Additional details are available on the METHYLPHENIDATE profile page.

The generic ingredient in METHYLPHENIDATE 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 206497
Tradename:METHYLPHENIDATE
Applicant:Mylan Tech Viatris
Ingredient:methylphenidate
Patents:0
Pharmacology for NDA: 206497
Medical Subject Heading (MeSH) Categories for 206497
Suppliers and Packaging for NDA: 206497
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 206497 ANDA Mylan Pharmaceuticals Inc. 0378-8260 0378-8260-93 30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH
METHYLPHENIDATE methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 206497 ANDA Mylan Pharmaceuticals Inc. 0378-8261 0378-8261-93 30 POUCH in 1 CARTON (0378-8261-93) / 1 PATCH in 1 POUCH (0378-8261-16) / 9 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MG/9HR (1.1MG/HR)
Approval Date:Mar 14, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength15MG/9HR (1.6MG/HR)
Approval Date:Mar 14, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength20MG/9HR (2.2MG/HR)
Approval Date:Mar 14, 2022TE:ABRLD:No

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