ANDA 212081, held by Nang Kuang Pharm Co. Icatibant Acetate.
As of Nov 15, 2026, ANDA 212081 (Icatibant Acetate), held by Nang Kuang Pharm Co, was first approved by FDA on Dec 16, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 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
