Treats advanced renal cell carcinoma. ANDA 207383, held by Gland. Temsirolimus.
As of Nov 14, 2026, ANDA 207383 (Temsirolimus), held by Gland, was first approved by FDA on Aug 16, 2019, with 0 approved supplements and 0 published complete response letters.
Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Temsirolimus25MG/ML (25MG/ML) · solution;intravenous | Temsirolimus | 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
