BLA 761100, held by Samsung Bioepis Co Ltd. Trastuzumab-Dttb.
As of Nov 13, 2026, BLA 761100 (Ontruzant), held by Samsung Bioepis Co Ltd, was first approved by FDA on Jan 18, 2019, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ontruzant150MG · powder;iv (infusion) | Trastuzumab-Dttb | Rx |
| Ontruzant420MG · powder;iv (infusion) | Trastuzumab-Dttb | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2026 | Supplement 30Labeling · Standard review | Approved | None posted |
| Dec 5, 2025 | Supplement 28Labeling · Standard review | Approved | |
| Feb 28, 2025 | Supplement 25Bioequivalence | Approved | |
| Mar 19, 2020 | Supplement 5Manufacturing | Approved | |
| Jan 18, 2019 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
