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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021259

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NDA 021259 describes METADATE CD, which is a drug marketed by Lannett Co Inc and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the METADATE CD profile page.

The generic ingredient in METADATE CD is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 021259
Tradename:METADATE CD
Applicant:Lannett Co Inc
Ingredient:methylphenidate hydrochloride
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021259
Suppliers and Packaging for NDA: 021259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METADATE CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259 NDA Unither Manufacturing, LLC 53014-579 N 53014-579-07
METADATE CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259 NDA Unither Manufacturing, LLC 53014-580 N 53014-580-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Apr 3, 2001TE:AB2RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 19, 2003TE:AB2RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 27, 2003TE:AB2RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?

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