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Last Updated: December 12, 2019

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 one supplier. 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. Eighty-three suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 090906
Applicant:Lotus Pharm Co Ltd
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 OWP Pharmaceuticals, Inc. 69102-101 69102-101-01 120 TABLET, FILM COATED in 1 BOTTLE (69102-101-01)
ROWEEPRA levetiracetam TABLET;ORAL 090906 ANDA OWP Pharmaceuticals, Inc. 69102-102 69102-102-01 120 TABLET, FILM COATED in 1 BOTTLE (69102-102-01)

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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