BLA 761042, held by Sandoz. Etanercept-Szzs.
As of Nov 13, 2026, BLA 761042 (Erelzi), held by Sandoz, was first approved by FDA on Aug 30, 2016, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 10, 2022 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jun 11, 2020 | Supplement 12Efficacy (new indication or use) | Approved | |
| Oct 18, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Erelzi25MG/0.5ML · injectable; injection | Etanercept-Szzs | Rx |
| Erelzi50MG/ML · injectable; injection | Etanercept-Szzs | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 10, 2022 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jun 11, 2020 | Supplement 12Efficacy (new indication or use) | Approved | |
| Oct 18, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Aug 30, 2016 | 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
