Treats superficial infections of the external auditory canal caused by organisms…. ANDA 40607, held by Sciegen Pharms. Acetic Acid, Glacial.
As of Nov 15, 2026, ANDA 40607 (Acetic Acid), held by Sciegen Pharms, was first approved by FDA on Feb 24, 2005, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetic Acid2% · solution/drops;otic | Acetic Acid, Glacial | Rx |
| Jun 14, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 24, 2005 | 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
