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RITALIN Drug Profile

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Ritalin is a drug marketed by Novartis and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in RITALIN is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: RITALIN

Suppliers / Packagers: see list4
Bulk Api Vendors: see list44
Clinical Trials: see list72
Patent Applications: see list6,098
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RITALIN at DailyMed

Pharmacology for Tradename: RITALIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
methylphenidate hydrochloride
TABLET;ORAL010187-003Approved Prior to Jan 1, 1982RXYesNo► subscribe► subscribe
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002RXYesNo6,228,398► subscribeY ► subscribe
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004RXYesNo6,228,398► subscribeY ► subscribe
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Paragraph IV activity for: RITALIN

Drugname Dosage Strength RLD Submissiondate
metformin hydrochlorideExtended-release Capsules10 mgRitalin LA5/21/2007
metformin hydrochlorideExtended-release Capsules20 mg, 30 mg and 40 mgRitalin LA8/21/2006
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