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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Federal Trade Commission
US Department of Justice

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018332

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NDA 018332 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 018332
Applicant:Iroko Pharms
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOCIN indomethacin SUSPENSION;ORAL 018332 NDA Iroko Pharmaceuticals, LLC 42211-101 N 42211-101-01
INDOCIN indomethacin SUSPENSION;ORAL 018332 NDA Iroko Pharmaceuticals, LLC 42211-101 N 42211-101-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:Oct 10, 1985TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Fish and Richardson
Daiichi Sankyo

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