The FDA’s database for NDA 018858 lists two oral capsule products marketed under the brand name INDOMETHACIN. Product 001 is a 25 mg capsule and product 002 is a 50 mg capsule; both are recorded as discontinued.
A total of ten supplemental submissions (submission numbers 4, 6, 8, 13, 15, 17, 23, 25, 28, 38) received approval (status AP) between 1985 and 2008. These submissions cover manufacturing (CMC) and labeling categories.
The most recent activity is submission 42, a labeling supplement approved in 2016. The FDA provided a labeling document (018858s041s042lbl.pdf) dated 2016‑05‑11 and an accompanying approval letter (018858Orig1s041,s042ltr.pdf) dated 2016‑05‑12.
All listed submissions are marked as approved, indicating ongoing regulatory compliance despite the discontinuation of the marketed products.
法规动态2026年9月16日•3 分钟阅读
FDA Approves Multiple Submissions for Indomethacin NDA 018858, Products Discontinued
The FDA has approved a series of manufacturing and labeling submissions for Indomethacin (NDA 018858). Both listed capsule products (25 mg and 50 mg) are marked discontinued.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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