NDA 50509, held by Wyeth Ayerst. Cyclacillin.
As of Nov 13, 2026, NDA 50509 (Cyclapen-W), held by Wyeth Ayerst, was first approved by FDA on Sep 13, 1979, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 1979 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyclapen-W250MG · tablet;oral | Cyclacillin | Discontinued |
| Cyclapen-W500MG · tablet;oral | Cyclacillin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 20, 1987 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 9, 1985 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1985 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1984 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Mar 8, 1982 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 30, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1980 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1979 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1979 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 13, 1979 | Original applicationNew dosage form · 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
