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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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US Army
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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021519

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NDA 021519 describes LUVOX, which is a drug marketed by Ani Pharms, Solvay, and Jazz Pharms, and is included in three NDAs. It is available from three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the LUVOX profile page.

The generic ingredient in LUVOX is fluvoxamine maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

Summary for 021519

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021519

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUVOX
fluvoxamine maleate
TABLET;ORAL 021519 NDA AUTHORIZED GENERIC Aidarex Pharmaceuticals LLC 33261-683 33261-683-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (33261-683-30)
LUVOX
fluvoxamine maleate
TABLET;ORAL 021519 NDA REMEDYREPACK INC. 49349-991 49349-991-02 30 TABLET in 1 BLISTER PACK (49349-991-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 20, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 20, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 20, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Daiichi Sankyo
UBS
Boehringer Ingelheim
Johnson and Johnson
Colorcon
McKinsey
Citi
US Army

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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