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Last Updated: January 15, 2021

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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-two drug master file entries for this compound. Forty-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
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 0406-3005-50 500 mL in 1 BOTTLE (0406-3005-50)
METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419 NDA AUTHORIZED GENERIC SpecGx LLC 0406-3010 0406-3010-50 500 mL in 1 BOTTLE (0406-3010-50)
Paragraph IV (Patent) Challenges for 021419
Tradename Dosage Ingredient NDA Submissiondate
METHYLIN SOLUTION;ORAL methylphenidate hydrochloride 021419 2010-04-13

Profile for product number 001

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

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