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Details for New Drug Application (NDA): 021259

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NDA 021259 describes METADATE CD, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from three 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-five suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 021259

Tradename:
METADATE CD
Applicant:
Ucb 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 53014-579-07 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53014-579-07)
METADATE CD
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 021259 NDA Unither Manufacturing, LLC 53014-580 53014-580-07 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53014-580-07)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Apr 3, 2001TE:AB2RLD:No
Patent:6,344,215Patent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 19, 2003TE:AB2RLD:No
Patent:6,344,215Patent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 27, 2003TE:AB2RLD:No
Patent:6,344,215Patent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?


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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 verifification 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.

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