ANDA 74517, held by Chartwell Rx. Guanabenz Acetate.
As of Nov 15, 2026, ANDA 74517 (Guanabenz Acetate), held by Chartwell Rx, was first approved by FDA on Sep 30, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1998 | Original application | Approved |
| Guanabenz AcetateEQ 4MG BASE · tablet;oral | Guanabenz Acetate | Discontinued |
| Guanabenz AcetateEQ 8MG BASE · tablet;oral | Guanabenz Acetate | 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
