Butisol Sodium

NDA 793, held by Pharmobedient. Butabarbital Sodium.

As of Nov 14, 2026, NDA 793 (Butisol Sodium), held by Pharmobedient, was first approved by FDA on Jun 5, 1939, with 24 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1939
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jun 5, 1939	Original application	Approved	None posted

Products

4 strengths and forms


Butisol Sodium15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Butabarbital Sodium	Discontinued
Butisol Sodium50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Butabarbital Sodium	Discontinued
Butisol Sodium30MG · tablet;oral	Butabarbital Sodium	DiscontinuedReference drug
Butisol Sodium100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Butabarbital Sodium	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Feb 6, 2019	Supplement 26Labeling	Approved	Letter Label
Sep 28, 2007	Supplement 25Labeling · Standard review	Approved	Letter Label
Oct 23, 2002	Supplement 24Manufacturing	Approved	None posted
May 2, 2000	Supplement 20Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 23Manufacturing	Approved	None posted
Jan 21, 2000	Supplement 22Manufacturing	Approved	None posted
Nov 13, 1998	Supplement 21Manufacturing	Approved	None posted
Nov 4, 1998	Supplement 15Labeling	Approved	None posted
Jan 14, 1993	Supplement 18Manufacturing	Approved	None posted
Nov 2, 1992	Supplement 19Manufacturing	Approved	None posted
Jan 15, 1987	Supplement 17Manufacturing	Approved	None posted
Sep 26, 1986	Supplement 16Manufacturing	Approved	None posted
Jun 15, 1984	Supplement 13Manufacturing	Approved	None posted
Feb 29, 1984	Supplement 14Manufacturing	Approved	None posted
Nov 22, 1983	Supplement 12Manufacturing	Approved	None posted
Nov 22, 1983	Supplement 11Labeling	Approved	None posted
Nov 22, 1983	Supplement 10Manufacturing	Approved	None posted
Nov 22, 1983	Supplement 9Manufacturing	Approved	None posted
Nov 8, 1982	Supplement 8Labeling	Approved	None posted
Feb 26, 1982	Supplement 7Labeling	Approved	None posted
Feb 16, 1979	Supplement 6Labeling	Approved	None posted
Feb 16, 1979	Supplement 5Labeling	Approved	None posted
Jun 2, 1978	Supplement 4Manufacturing	Approved	None posted
Nov 30, 1976	Supplement 3Manufacturing	Approved	None posted
Jun 5, 1939	Original application	Approved	None posted

Identifiers

Application: NDA 793
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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