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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 017814


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NDA 017814 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. Additional details are available on the indomethacin sodium profile page.
Summary for 017814
Tradename:INDOCIN
Applicant:Zyla Life Sciences
Ingredient:indomethacin
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 13, 1984TE:RLD:Yes

Expired US Patents for NDA 017814

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Zyla Life Sciences INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 ⤷  Sign Up ⤷  Sign Up
Zyla Life Sciences INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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