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Serving leading biopharmaceutical companies globally:

US Army
UBS
Moodys
Medtronic
Covington
AstraZeneca
Julphar
Cipla
Dow
McKinsey

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021419

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NDA 021419 describes METHYLIN, which is a drug marketed by Specgx Llc and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the METHYLIN profile page.

The generic ingredient in METHYLIN 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 021419
Tradename:METHYLIN
Applicant:Specgx Llc
Ingredient:methylphenidate hydrochloride
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021419
Suppliers and Packaging for NDA: 021419
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419 NDA AUTHORIZED GENERIC SpecGx LLC 0406-3005 N 0406-3005-50
METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419 NDA AUTHORIZED GENERIC SpecGx LLC 0406-3010 N 0406-3010-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Dec 19, 2002TE:AARLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Dec 19, 2002TE:AARLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2024Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
McKinsey
Cerilliant
Medtronic
Dow
Express Scripts
Argus Health
Deloitte
Boehringer Ingelheim

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.

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