ANDA 87260, held by Sanofi Aventis US. Phenylbutazone.
As of Nov 15, 2026, ANDA 87260 (Azolid), held by Sanofi Aventis US, was first approved by FDA on Oct 13, 1981, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azolid100MG ยท capsule;oral | Phenylbutazone | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
