ANDA 75792, held by Chartwell Injectable. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 75792 (Propranolol Hydrochloride), held by Chartwell Injectable, was first approved by FDA on Aug 29, 2000, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propranolol Hydrochloride1MG/ML ยท injectable;injection | Propranolol Hydrochloride | Discontinued |
| Sep 9, 2008 | Supplement 8Labeling | Approved | None posted |
| May 1, 2007 | Supplement 7Labeling | Approved | None posted |
| Mar 13, 2002 | Supplement 2Labeling | Approved | None posted |
| Apr 3, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Aug 29, 2000 | Original application | Approved |
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
