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Last Updated: May 28, 2024

Details for New Drug Application (NDA): 018332

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NDA 018332 describes INDOCIN, which is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla, 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. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 018332
Formulation / Manufacturing:see details
Pharmacology for NDA: 018332
Mechanism of ActionCyclooxygenase Inhibitors
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 Zyla Life Sciences US LLC 69344-101 69344-101-01 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS

Profile for product number 001

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

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