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Generated: June 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209150

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NDA 209150 describes THIOTEPA, which is a drug marketed by Dr Reddys Labs Ltd, Fresenius Kabi Usa, Immunex, Jiangsu Hengrui Med, Teva Parenteral, and West-ward Pharms Int, and is included in six NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 209150
Tradename:THIOTEPA
Applicant:Jiangsu Hengrui Med
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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