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Details for New Drug Application (NDA): 021475

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NDA 021475 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: 021475

Tradename:
METHYLIN
Applicant:
Mallinckrodt
Ingredient:
methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021475

Suppliers and Packaging for NDA: 021475

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLIN
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL 021475 NDA SHIONOGI INC. 59630-760 59630-760-10 100 TABLET, CHEWABLE in 1 BOTTLE (59630-760-10)
METHYLIN
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL 021475 NDA SHIONOGI INC. 59630-761 59630-761-10 100 TABLET, CHEWABLE in 1 BOTTLE (59630-761-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 15, 2003TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 15, 2003TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 15, 2003TE:RLD:No


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