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Last Updated: December 17, 2025

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 one supplier. 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:	0

Pharmacology for NDA: 021419

Physiological Effect	Central Nervous System Stimulation

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	SHIONOGI INC.	59630-750	59630-750-50	500 mL in 1 BOTTLE (59630-750-50)
METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419	NDA	SHIONOGI INC.	59630-755	59630-755-50	500 mL in 1 BOTTLE (59630-755-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Dec 19, 2002	TE:	AA	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/5ML
Approval Date:	Dec 19, 2002	TE:	AA	RLD:	Yes

Expired US Patents for NDA 021419

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-001	Dec 19, 2002	⤷ Get Started Free	⤷ Get Started Free
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-002	Dec 19, 2002	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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