ANDA 77015, held by Fougera Pharms. Sulfacetamide Sodium.
As of Nov 15, 2026, ANDA 77015 (Sulfacetamide Sodium), held by Fougera Pharms, was first approved by FDA on Nov 17, 2006, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2006 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sulfacetamide Sodium10% · lotion;topical | Sulfacetamide Sodium | Rx |
| Jan 3, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 17, 2006 | 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
