NDA 18976, held by Endo Operations. Penbutolol Sulfate.
As of Nov 14, 2026, NDA 18976 (Levatol), held by Endo Operations, was first approved by FDA on Dec 30, 1987, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 1987 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Levatol10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Penbutolol Sulfate | DiscontinuedReference drug |
| Levatol20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Penbutolol Sulfate | DiscontinuedReference drug |
| May 3, 2011 | Supplement 12Labeling | Approved | |
| Feb 6, 2001 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 25, 2000 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1999 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1996 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 12, 1996 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1993 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1990 | Supplement 3Labeling | Approved | None posted |
| Jan 5, 1989 | Supplement 2Labeling | Approved | None posted |
| Oct 26, 1988 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1987 | Original applicationNew molecular entity · Standard review | 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
