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Last Updated: December 14, 2025

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. 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. Forty-six 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Jun 1, 1988	TE:		RLD:	No

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