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Boehringer Ingelheim
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QuintilesIMS
US Army
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078873

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NDA 078873 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, Ascent Pharms Inc, Tedor Pharma Inc, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Cnty Line Pharms, Lannett Co Inc, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Bionpharma Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in forty-four 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-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 078873
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Teva Pharms
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078873
Suppliers and Packaging for NDA: 078873
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078873 ANDA Teva Pharmaceuticals USA, Inc. 0093-5292 N 0093-5292-01
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078873 ANDA Teva Pharmaceuticals USA, Inc. 0093-5293 N 0093-5293-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jul 19, 2012TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Jul 19, 2012TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Jul 19, 2012TE:AB2RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
UBS
Federal Trade Commission
Chubb
Teva
Argus Health
Healthtrust
Boehringer Ingelheim
Daiichi Sankyo

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