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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Deloitte
Colorcon
Daiichi Sankyo
Accenture
Covington
Mallinckrodt
US Army
Baxter

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016059

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NDA 016059 describes INDOCIN, which is a drug marketed by Iroko Pharms Llc, Recordati Rare, and Iroko Pharms, and is included in five NDAs. It is available from one supplier. Additional details are available on the INDOCIN profile page.

The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 016059
Tradename:INDOCIN
Applicant:Iroko Pharms Llc
Ingredient:indomethacin
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
McKinsey
Chubb
Argus Health
Citi
AstraZeneca
Medtronic
Johnson and Johnson
Farmers Insurance

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