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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018185

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NDA 018185 describes INDOCIN SR, which is a drug marketed by Egalet and is included in one NDA. Additional details are available on the INDOCIN SR profile page.

The generic ingredient in INDOCIN SR is indomethacin. There are fifteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the indomethacin profile page.
Summary for 018185
Tradename:INDOCIN SR
Applicant:Egalet
Ingredient:indomethacin
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 018185
Tradename Dosage Ingredient NDA Submissiondate
INDOCIN SR CAPSULE, EXTENDED RELEASE;ORAL indomethacin 018185

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 23, 1982TE:RLD:Yes

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