Details for New Drug Application (NDA): 021419

✉ Email this page to a colleague

NDA 021419 describes METHYLIN, which is a drug marketed by Specgx Llc and is included in three NDAs. It is available from one supplier. 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-six 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

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
Patent:	⤷ Sign Up	Patent Expiration:	Oct 7, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

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
Patent:	⤷ Sign Up	Patent Expiration:	Oct 7, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021419

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-001	Dec 19, 2002	⤷ Sign Up	⤷ Sign Up
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-002	Dec 19, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.