ANDA 86845, held by Warner Chilcott. Acetic Acid, Glacial.
As of Nov 15, 2026, ANDA 86845 (Orlex), held by Warner Chilcott, was first approved by FDA on Oct 26, 1979, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 26, 1979 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orlex2% ยท solution/drops;otic | Acetic Acid, Glacial | Discontinued |
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
