Treats advanced renal cell carcinoma. ANDA 203153, held by Accord Hlthcare. Temsirolimus.
As of Nov 14, 2026, ANDA 203153 (Temsirolimus), held by Accord Hlthcare, was first approved by FDA on Jul 30, 2018, with 1 approved supplement and 0 published complete response letters.
Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Temsirolimus25MG/ML (25MG/ML) · solution;intravenous | Temsirolimus | Rx |
| Feb 11, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 30, 2018 | 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
