Treats Unresectable hepatocellular carcinoma Locally recurrent or metastatic…. ANDA 209050, held by Yabao Pharm. Sorafenib Tosylate.
As of Nov 15, 2026, ANDA 209050 (Sorafenib Tosylate), held by Yabao Pharm, was first approved by FDA on Nov 9, 2022, with 2 approved supplements and 0 published complete response letters.
Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular 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). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sorafenib TosylateEQ 200MG BASE · tablet;oral | Sorafenib Tosylate | Rx |
| Sep 12, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 12, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 9, 2022 | 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
