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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Army
US Department of Justice
Johnson and Johnson

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075629

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NDA 075629 describes METHYLIN ER, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the METHYLIN ER profile page.

The generic ingredient in METHYLIN ER 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 075629
Applicant:Specgx Llc
Ingredient:methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075629
Suppliers and Packaging for NDA: 075629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629 ANDA SpecGx LLC 0406-1445 N 0406-1445-01
METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629 ANDA SpecGx LLC 0406-1473 N 0406-1473-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 9, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:May 9, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Express Scripts
US Army
Harvard Business School

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