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TEPADINA

thiotepa · Injection, Powder, Lyophilized, for Solution

Prescription NDA TE AP RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
TEPADINA
Generic name
thiotepa
Dosage form
Injection, Powder, Lyophilized, for Solution
Route
Intracavitary
Marketing category
NDA · NDA
Labeler
Amneal Pharmaceuticals LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Thiotepa 200 mg/1 1660004 View
Thiotepa 400 mg/1 1660004 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Powder, Lyophilized, for Solution
Route of administration
Intracavitary
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Alkylating Activity [MoA] MoA All 23 members
Alkylating Drug [EPC] EPC All 23 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
208264
Application type
NDA · New Drug Application
Approval date
January 26, 2017
Sponsor
ADIENNE SA
Products on application
4
Submissions recorded
6
Products approved under application 208264.
Product Trade name Form Strength Ingredient Status TE Flags
208264-001 TEPADINA POWDER THIOTEPA Prescription AP RLD RS
208264-002 TEPADINA POWDER THIOTEPA Prescription AP RLD RS
208264-003 TEPADINA AND SODIUM CHLORIDE POWDER THIOTEPA Prescription — RLD RS
208264-004 TEPADINA AND SODIUM CHLORIDE POWDER THIOTEPA Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9931458 May 31, 2037 003 No May 9, 2025
9931458 May 31, 2037 004 No February 12, 2026

Approval history

Source: Drugs@FDA
Most recent submissions on application 208264.
Type No. Action Status Date Review
Supplement 8 Manufacturing (CMC) Approved January 15, 2026 N/A
Supplement 7 Manufacturing (CMC) Approved October 2, 2025 N/A
Supplement 6 Manufacturing (CMC) Approved April 10, 2025 N/A
Supplement 3 Manufacturing (CMC) Approved March 13, 2020 N/A
Supplement 1 Labeling Approved December 27, 2019 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved January 26, 2017 Standard

Review documents

  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · May 23, 2023
  • 0 · Supplement · May 19, 2023
  • 0 · Supplement · December 31, 2019
  • 0 · Original application · July 6, 2018
  • 0 · Original application · January 30, 2017
  • 0 · Original application · January 26, 2017

Adverse event reports

Source: openFDA FAERS
9,494
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: THIOTEPA. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
70121-1687-1 70121-1687 Amneal Pharmaceuticals LLC 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-1687-1) April 18, 2025
70121-2749-1 70121-2749 Amneal Pharmaceuticals LLC 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1) April 18, 2025
70121-1687 70121-1687 Amneal Pharmaceuticals LLC — April 18, 2025
70121-2749 70121-2749 Amneal Pharmaceuticals LLC — April 18, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.