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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 Ucb Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the METADATE ER profile page.

The generic ingredient in METADATE ER is methylphenidate hydrochloride. There are thirty 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: 089601

Ucb Inc
methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 089601

Suppliers and Packaging for NDA: 089601

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 089601 ANDA Upstate Pharma, LLC 65580-594 65580-594-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65580-594-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 1, 1988TE:ABRLD:Yes

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