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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216037


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NDA 216037 describes THIOTEPA, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Regcon Holdings, Teva Parenteral, West-ward Pharms Int, Gland, Hikma, Meitheal, and MSN, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the THIOTEPA profile page.

The generic ingredient in THIOTEPA is thiotepa. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 216037
Tradename:THIOTEPA
Applicant:Meitheal
Ingredient:thiotepa
Patents:0
Pharmacology for NDA: 216037
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 216037
Antineoplastic Agents, Alkylating
Myeloablative Agonists
Suppliers and Packaging for NDA: 216037
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 216037 ANDA Meitheal Pharmaceuticals Inc 71288-156 71288-156-05 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 216037 ANDA Meitheal Pharmaceuticals Inc 71288-157 71288-157-10 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICALStrength15MG/VIAL
Approval Date:Dec 26, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICALStrength100MG/VIAL
Approval Date:Dec 26, 2023TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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