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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Medtronic
Fuji
Moodys
Dow
Teva
US Department of Justice
Baxter

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090906

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NDA 090906 describes ROWEEPRA, which is a drug marketed by Lotus Pharm Co Ltd and is included in one NDA. It is available from four suppliers. Additional details are available on the ROWEEPRA profile page.

The generic ingredient in ROWEEPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Ninety-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 090906
Tradename:ROWEEPRA
Applicant:Lotus Pharm Co Ltd
Ingredient:levetiracetam
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090906
Suppliers and Packaging for NDA: 090906
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROWEEPRA levetiracetam TABLET;ORAL 090906 ANDA Trigen Laboratories, Inc. 13811-621 E 13811-621-12
ROWEEPRA levetiracetam TABLET;ORAL 090906 ANDA Trigen Laboratories, Inc. 13811-621 E 13811-621-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 5, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 31, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Oct 31, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Medtronic
Farmers Insurance
Cantor Fitzgerald
US Army
Baxter
Chinese Patent Office
Daiichi Sankyo

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