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Generated: January 22, 2019

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Details for New Drug Application (NDA): 021284

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NDA 021284 describes RITALIN LA, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RITALIN LA profile page.

The generic ingredient in RITALIN LA is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 021284
Tradename:RITALIN LA
Applicant:Novartis
Ingredient:methylphenidate hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021284
Suppliers and Packaging for NDA: 021284
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NDA Novartis Pharmaceuticals Corporation 0078-0370 0078-0370-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0370-05)
RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NDA Novartis Pharmaceuticals Corporation 0078-0371 0078-0371-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0371-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES

Expired US Patents for NDA 021284

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-004 Apr 10, 2004 ➤ Sign Up ➤ Sign Up
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-002 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-002 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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