ANDA 212296, held by Wilshire Pharms Inc. Deoxycholic Acid.
As of Nov 15, 2026, ANDA 212296 (Deoxycholic Acid), held by Wilshire Pharms Inc, was first approved by FDA on Apr 2, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Deoxycholic Acid20MG/2ML (10MG/ML) · solution;subcutaneous | Deoxycholic Acid | Rx |
| Jun 29, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 2, 2021 | 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
