ANDA 86101, held by Valeant Pharms North. Secobarbital Sodium.
As of Nov 15, 2026, ANDA 86101 (Seconal Sodium), held by Valeant Pharms North, was first approved by FDA on Oct 3, 1983, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 1983 | Original application | Approved | None posted |
| Seconal Sodium50MG · capsule;oral | Secobarbital Sodium | Discontinued |
| Seconal Sodium100MG · capsule;oral | Secobarbital Sodium | Discontinued |
| Jun 8, 2018 | Supplement 23Labeling · Standard review | Approved | None posted |
| Aug 20, 2008 | Supplement 21Labeling | Approved | None posted |
| Jun 27, 2007 | Supplement 20Labeling | Approved | None posted |
| Sep 25, 2003 | Supplement 17Labeling | Approved | None posted |
| Aug 20, 2003 | Supplement 15Labeling | Approved | None posted |
| Sep 9, 1998 | Supplement 11Manufacturing | Approved | None posted |
| Mar 17, 1998 | Supplement 10Manufacturing | Approved | None posted |
| Jul 7, 1995 | Supplement 9Manufacturing | Approved | None posted |
| Mar 28, 1991 | Supplement 8Labeling | Approved | None posted |
| Oct 3, 1990 | Supplement 6Labeling | Approved | None posted |
| Aug 2, 1989 | Supplement 5Labeling | Approved | None posted |
| Sep 9, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Aug 24, 1988 | Supplement 1Bioequivalence | Approved | None posted |
| Jul 3, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Jul 3, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Oct 3, 1983 | Original application | Approved | None posted |
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
