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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 209150


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NDA 209150 describes THIOTEPA, which is a drug marketed by Beloteca, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Teva Parenteral, West-ward Pharms Int, Gland Pharma Ltd, Hikma, Kindos, and MSN, and is included in twelve 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. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 209150
Tradename:THIOTEPA
Applicant:Hengrui Pharma
Ingredient:thiotepa
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209150
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 209150
Suppliers and Packaging for NDA: 209150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIOTEPA thiotepa INJECTABLE;INJECTION 209150 ANDA Sagent Pharmaceuticals 25021-246 25021-246-02 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/VIAL
Approval Date:May 4, 2018TE:APRLD:No

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