Banthine

NDA 7390, held by Shire. Methantheline Bromide.

As of Nov 13, 2026, NDA 7390 (Banthine), held by Shire, was first approved by FDA on Jul 3, 1951, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1951
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 3, 1951	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Banthine50MG · tablet;oral	Methantheline Bromide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 2, 1990	Supplement 14Labeling	Approved	None posted
Feb 2, 1990	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 19, 1987	Supplement 15Labeling	Approved	None posted
Jul 3, 1951	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 7390
Drugs@FDA: Overview at FDA
Company: Shire

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