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Details for New Drug Application (NDA): 075629

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NDA 075629 describes METHYLIN ER, which is a drug marketed by Mallinckrodt Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the METHYLIN ER profile page.

The generic ingredient in METHYLIN ER is methylphenidate hydrochloride. There are twenty-nine drug master file entries for this compound. Thirty-three 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: 075629

Mallinckrodt Inc
methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 075629

Suppliers and Packaging for NDA: 075629

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 075629 ANDA Mallinckrodt, Inc. 0406-1445 0406-1445-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1445-01)
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 075629 ANDA Mallinckrodt, Inc. 0406-1473 0406-1473-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 9, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:May 9, 2000TE:ABRLD:No

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