Treats peptic ulcer. ANDA 200602, held by Unichem. Methscopolamine Bromide.
As of Nov 15, 2026, ANDA 200602 (Methscopolamine Bromide), held by Unichem, was first approved by FDA on Sep 24, 2012, with 1 approved supplement 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 |
|---|---|---|---|
| Sep 24, 2012 | Original application | Approved | None posted |
| Methscopolamine Bromide2.5MG · tablet;oral | Methscopolamine Bromide | Rx |
| Methscopolamine Bromide5MG · tablet;oral | Methscopolamine Bromide | Rx |
| Apr 23, 2019 | Supplement 5Manufacturing | Approved | None posted |
| Sep 24, 2012 | Original application | Approved | None posted |
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
