ANDA 85869, held by Ivax Pharms. Secobarbital Sodium.
As of Nov 15, 2026, ANDA 85869 (Secobarbital Sodium), held by Ivax Pharms, was first approved by FDA on Oct 25, 1977, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 25, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Secobarbital Sodium100MG ยท capsule;oral | Secobarbital Sodium | 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
