ANDA 80517, held by Watson Labs. Prednisolone Sodium Phosphate.
As of Nov 15, 2026, ANDA 80517 (Prednisolone Sodium Phosphate), held by Watson Labs, was first approved by FDA on Jan 29, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 29, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Sodium PhosphateEQ 20MG PHOSPHATE/ML ยท injectable;injection | Prednisolone Sodium Phosphate | 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