Treats Unresectable hepatocellular carcinoma Advanced renal cell carcinoma Locally…. ANDA 209567, held by Teva Pharms USA Inc. Sorafenib Tosylate.
As of Nov 15, 2026, ANDA 209567 (Sorafenib Tosylate), held by Teva Pharms USA Inc, was first approved by FDA on Nov 12, 2020, with 1 approved supplement and 0 published complete response letters.
Sorafenib is a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma Advanced renal cell carcinoma Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 12, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sorafenib TosylateEQ 200MG BASE · tablet;oral | Sorafenib Tosylate | Rx |
| Sep 12, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 12, 2020 | Original application | Approved | None posted |
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
