Treats acne vulgaris. ANDA 78649, held by Padagis US. Sulfacetamide Sodium.
As of Nov 15, 2026, ANDA 78649 (Sulfacetamide Sodium), held by Padagis US, was first approved by FDA on Mar 23, 2009, with 1 approved supplement and 0 published complete response letters.
INDICATIONS Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sulfacetamide Sodium10% · lotion;topical | Sulfacetamide Sodium | Rx |
| Apr 29, 2015 | Supplement 2Labeling | Approved | None posted |
| Mar 23, 2009 | 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
