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Generated: November 20, 2018

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Details for New Drug Application (NDA): 089601

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NDA 089601 describes METADATE ER, which is a drug marketed by Lannett Co Inc and is included in two NDAs. It is available from three suppliers. Additional details are available on the METADATE ER profile page.

The generic ingredient in METADATE ER is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 089601
Tradename:METADATE ER
Applicant:Lannett Co Inc
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089601
Suppliers and Packaging for NDA: 089601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METADATE ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 089601 ANDA Lannett Company, Inc. 0527-2562 0527-2562-37 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2562-37)
METADATE ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 089601 ANDA Unither Manufacturing, LLC 53014-594 53014-594-07 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53014-594-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 1, 1988TE:ABRLD:No

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