ANDA 80977, held by Pvt Form. Propantheline Bromide.
As of Nov 15, 2026, ANDA 80977 (Propantheline Bromide), held by Pvt Form, was first approved by FDA on Aug 4, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propantheline Bromide15MG ยท tablet;oral | Propantheline 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
