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Details for New Drug Application (NDA): 086428

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NDA 086428 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Mallinckrodt, Tris Pharma Inc, Novel Labs Inc, Able, Corepharma, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Actavis Elizabeth, Ucb Inc, Barr Labs Inc, Cnty Line Pharms, Mayne Pharma, Nostrum Labs Inc, Abhai, Vintage Pharms, and Kremers Urban Pharms, and is included in thirty NDAs. It is available from twenty-seven suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE 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: 086428

Ucb Inc
methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 086428

Suppliers and Packaging for NDA: 086428

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methylphenidate hydrochloride
TABLET;ORAL 086428 ANDA Unither Manufacturing, LLC 53014-532 53014-532-07 100 TABLET in 1 BOTTLE (53014-532-07)
methylphenidate hydrochloride
TABLET;ORAL 086428 ANDA Physicians Total Care, Inc. 54868-3454 54868-3454-0 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-3454-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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