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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cipla
Johnson and Johnson
Farmers Insurance
Fish and Richardson
Harvard Business School
Express Scripts
Deloitte
QuintilesIMS
UBS

Generated: October 16, 2017

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, Iroko Pharms Llc, and Recordati Rare, 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 NDA: 018332

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018332

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 42211-101-01 1 BOTTLE in 1 CARTON (42211-101-01) > 50 mL in 1 BOTTLE
INDOCIN
indomethacin
SUSPENSION;ORAL 018332 NDA Iroko Pharmaceuticals, LLC 42211-101 42211-101-11 1 BOTTLE in 1 CARTON (42211-101-11) > 237 mL in 1 BOTTLE

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
Express Scripts
Covington
Johnson and Johnson
McKesson
Healthtrust
Daiichi Sankyo
Fish and Richardson
Merck

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