ANDA 70667, held by Chartwell Rx. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 70667 (Propranolol Hydrochloride), held by Chartwell Rx, was first approved by FDA on Jun 13, 1986, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propranolol Hydrochloride80MG ยท tablet;oral | Propranolol Hydrochloride | Discontinued |
| May 9, 2001 | Supplement 15Manufacturing | Approved | None posted |
| May 18, 1995 | Supplement 14Manufacturing | Approved | None posted |
| May 22, 1992 | Supplement 13Labeling | Approved | None posted |
| Jul 10, 1989 | Supplement 12Labeling | Approved | None posted |
| Dec 23, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Dec 23, 1988 | Supplement 9Manufacturing | Approved | None posted |
| Dec 23, 1988 | Supplement 6Labeling | Approved | None posted |
| Dec 23, 1988 | Supplement 5Manufacturing | Approved | None posted |
| Dec 23, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Nov 29, 1988 | Supplement 11Labeling | Approved | None posted |
| Feb 11, 1988 | Supplement 8Manufacturing | Approved | None posted |
| Jul 31, 1987 | Supplement 7Labeling | Approved | None posted |
| Feb 5, 1987 | Supplement 3Labeling | Approved | None posted |
| Feb 5, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Nov 19, 1986 | Supplement 2Labeling | Approved | None posted |
| Jun 13, 1986 | Original application | Approved | None posted |
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