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Generated: May 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207901

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NDA 207901 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Tris Pharma Inc, Teva Pharms, Impax Labs Inc, Teva Pharms Usa, Abhai Inc, Sun Pharm Inds, Novel Labs Inc, Par Pharm Inc, Mylan Pharms Inc, and Intellipharmaceutics, and is included in twelve NDAs. It is available from sixteen suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for NDA: 207901

Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 207901

Suppliers and Packaging for NDA: 207901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dexmethylphenidate hydrochloride
TABLET;ORAL 207901 ANDA Tris Pharma Inc 27808-091 27808-091-01 100 TABLET in 1 BOTTLE, PLASTIC (27808-091-01)
dexmethylphenidate hydrochloride
TABLET;ORAL 207901 ANDA Tris Pharma Inc 27808-092 27808-092-01 100 TABLET in 1 BOTTLE (27808-092-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 26, 2016TE:ABRLD:No

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