Secobarbital Sodium

ANDA 83262, held by Wyeth Ayerst. Secobarbital Sodium.

As of Nov 15, 2026, ANDA 83262 (Secobarbital Sodium), held by Wyeth Ayerst, was first approved by FDA on Dec 3, 1973, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1973
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 3, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Secobarbital Sodium50MG/ML · injectable;injection	Secobarbital Sodium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jul 30, 1993	Supplement 10Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 9Manufacturing	Approved	None posted
Oct 24, 1989	Supplement 8Labeling	Approved	None posted
Dec 2, 1983	Supplement 6Manufacturing	Approved	None posted
Dec 3, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83262
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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