Treats peptic ulcer. ANDA 40642, held by Breckenridge Pharm. Methscopolamine Bromide.
As of Nov 15, 2026, ANDA 40642 (Methscopolamine Bromide), held by Breckenridge Pharm, was first approved by FDA on Dec 6, 2011, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 6, 2011 | Original application | Approved | None posted |
| Methscopolamine Bromide2.5MG · tablet;oral | Methscopolamine Bromide | Rx |
| Methscopolamine Bromide5MG · tablet;oral | Methscopolamine Bromide | 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
