Lotusate

NDA 9410, held by Sanofi Aventis US. Talbutal.

As of Nov 14, 2026, NDA 9410 (Lotusate), held by Sanofi Aventis US, was first approved by FDA on Sep 21, 1954, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 21, 1954
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 21, 1954	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lotusate120MG · tablet;oral	Talbutal	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 12, 1998	Supplement 5Labeling	Approved	None posted
May 12, 1998	Supplement 3Labeling	Approved	None posted
Oct 29, 1985	Supplement 8Labeling	Approved	None posted
Mar 15, 1982	Supplement 7Labeling	Approved	None posted
Apr 2, 1980	Supplement 6Labeling	Approved	None posted
Sep 21, 1954	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 9410
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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