ANDA 80970, held by Pvt Form. Methscopolamine Bromide.
As of Nov 15, 2026, ANDA 80970 (Methscopolamine Bromide), held by Pvt Form, was first approved by FDA on Oct 18, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methscopolamine Bromide2.5MG ยท tablet;oral | Methscopolamine Bromide | Discontinued |
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