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Active ingredient

Thiotepa

19 finished FDA listings contain Thiotepa as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
THIOTEPA
Dosage forms
Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
Routes
Intracavitary, Intravenous, Intravesical
Manufacturers / labelers
9
Strengths listed
10 mg/ml · 100 mg/1 · 15 mg/1 · 15 mg/1.5ml · 200 mg/1 · 400 mg/1
Brand names in FDA listings
Tepadina, Tepylute

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10473

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 075547WEST-WARD PHARMS INT2001-04-022
NDA 208264ADIENNE SA2017-01-264
ANDA 210337DR REDDYS2018-05-041
ANDA 209150HENGRUI PHARMA2018-05-041
ANDA 213049MSN2020-03-042
ANDA 214222GLAND2021-03-084
ANDA 211755HIKMA2023-09-051
ANDA 216037MEITHEAL2023-12-262
NDA 216984SHORLA2024-06-252

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.