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Generated: June 26, 2019

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Details for New Drug Application (NDA): 011683

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NDA 011683 describes THIOTEPA, which is a drug marketed by Dr Reddys, 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 011683
Tradename:THIOTEPA
Applicant:Immunex
Ingredient:thiotepa
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011683

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength15MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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