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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Mallinckrodt
Colorcon
Accenture
UBS
Moodys
Julphar
Medtronic
AstraZeneca

Generated: November 20, 2017

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-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for 090906

Tradename:
1
Applicant:
1
Ingredient:
1
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 13811-621-12 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13811-621-12)
ROWEEPRA
levetiracetam
TABLET;ORAL 090906 ANDA Trigen Laboratories, Inc. 13811-621 13811-621-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13811-621-50)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Accenture
Citi
QuintilesIMS
Cerilliant
Daiichi Sankyo
Fuji
Cipla
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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