NDA 50526, held by Westwood Squibb. Erythromycin.
As of Nov 14, 2026, NDA 50526 (Staticin), held by Westwood Squibb, was first approved by FDA on Jun 3, 1980, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 1980 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Staticin1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;topical | Erythromycin | DiscontinuedReference drug |
| Dec 15, 2002 | Supplement 10Labeling · Standard review | Approved | |
| Mar 13, 1995 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 10, 1986 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 23, 1983 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1982 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1981 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1980 | 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
