ANDA 87674, held by Watson Labs. Phenylbutazone.
As of Nov 15, 2026, ANDA 87674 (Phenylbutazone), held by Watson Labs, was first approved by FDA on Apr 21, 1982, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phenylbutazone100MG ยท tablet;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
