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Generated: January 23, 2019

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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
Tradename:INDOCIN
Applicant:Iroko Pharms
Ingredient:indomethacin
Patents:0
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 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

Profile for product number 001

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

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