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Treats adenocarcinoma of the breast or ovary. ANDA 214222, held by Gland. Thiotepa.
As of Nov 13, 2026, ANDA 214222 (Thiotepa), held by Gland, was first approved by FDA on Mar 8, 2021, with 1 approved supplement and 0 published complete response letters.
First approved: Mar 8, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Thiotepa for injection is an alkylating drug indicated:
For treatment of adenocarcinoma of the breast or ovary.
For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
For treatment of superficial papillary carcinoma of the urinary bladder. 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. 1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 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
