ANDA 84541, held by Impax Labs. Propantheline Bromide.
As of Nov 15, 2026, ANDA 84541 (Propantheline Bromide), held by Impax Labs, was not approved, with 0 approved supplements and 0 published complete response letters.
| 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
