Methscopolamine Bromide

ANDA 40624, held by Chartwell Rx. Methscopolamine Bromide.

As of Nov 15, 2026, ANDA 40624 (Methscopolamine Bromide), held by Chartwell Rx, was first approved by FDA on Dec 28, 2006, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 28, 2006
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 28, 2006	Original application	Approved	None posted

Products

2 strengths and forms


Methscopolamine Bromide2.5MG · tablet;oral	Methscopolamine Bromide	Discontinued
Methscopolamine Bromide5MG · tablet;oral	Methscopolamine Bromide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 26, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Dec 28, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 40624
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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