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Treats • Unresectable hepatocellular carcinoma. ANDA 207012, held by Mylan. Sorafenib Tosylate.
As of Nov 15, 2026, ANDA 207012 (Sorafenib Tosylate), held by Mylan, was first approved by FDA on Sep 10, 2020, with 1 approved supplement and 0 published complete response letters.
First approved: Sep 10, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Sorafenib tablets are 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.
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
