ANDA 211501, held by Wilshire Pharms Inc. Icatibant Acetate.
As of Nov 15, 2026, ANDA 211501 (Icatibant Acetate), held by Wilshire Pharms Inc, was first approved by FDA on Sep 2, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) ยท injectable;subcutaneous | Icatibant Acetate | Rx |
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
