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Details for New Drug Application (NDA): 021419

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NDA 021419 describes METHYLIN, which is a drug marketed by Mallinckrodt and Mallinckrodt Inc and is included in three NDAs. It is available from two suppliers. 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-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: 021419

Tradename:
METHYLIN
Applicant:
Mallinckrodt
Ingredient:
methylphenidate hydrochloride
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021419

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 AUTHORIZED GENERIC Mallinckrodt, Inc. 0406-3005 0406-3005-50 500 mL in 1 BOTTLE (0406-3005-50)
METHYLIN
methylphenidate hydrochloride
SOLUTION;ORAL 021419 NDA AUTHORIZED GENERIC Mallinckrodt, Inc. 0406-3010 0406-3010-50 500 mL in 1 BOTTLE (0406-3010-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Dec 19, 2002TE:AARLD:Yes
Patent:7,691,880Patent Expiration:Oct 7, 2024Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Dec 19, 2002TE:AARLD:Yes
Patent:7,691,880Patent Expiration:Oct 7, 2024Product 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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