Thiotepa

ANDA 75698, held by Fresenius Kabi USA. Thiotepa.

As of Nov 14, 2026, ANDA 75698 (Thiotepa), held by Fresenius Kabi USA, was first approved by FDA on Sep 20, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2001
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 20, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thiotepa15MG/VIAL · injectable;injection	Thiotepa	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Dec 5, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 1, 2002	Supplement 3Manufacturing	Approved	None posted
Sep 18, 2002	Supplement 2Manufacturing	Approved	None posted
Jul 11, 2002	Supplement 1Manufacturing	Approved	None posted
Sep 20, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75698
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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