BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Moodys
UBS
McKesson
McKinsey
Mallinckrodt
Queensland Health
Fish and Richardson
Julphar
Boehringer Ingelheim

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202892

« Back to Dashboard

NDA 202892 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mallinckrodt Inc, Mayne Pharma, Teva Pharms, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Tedor Pharma Inc, Able, Actavis Elizabeth, Cnty Line Pharms, Kremers Urban Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Ascent Pharms Inc, Mallinckrodt, Sun Pharm Inds Inc, Ucb Inc, and Vintage Pharms, and is included in thirty-eight NDAs. It is available from twenty-eight 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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 202892
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Vintage Pharms
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202892
Suppliers and Packaging for NDA: 202892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 202892 ANDA Par Pharmaceutical 0603-4576 0603-4576-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-4576-21)
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 202892 ANDA Par Pharmaceutical 0603-4577 0603-4577-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-4577-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 23, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 23, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 23, 2014TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Teva
Healthtrust
Dow
Cantor Fitzgerald
Merck
Fuji
Citi
Novartis

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot