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Federal Trade Commission
Fish and Richardson
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Citi
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Chinese Patent Office
Cantor Fitzgerald
Colorcon
Fuji

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075547

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NDA 075547 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 two suppliers. Additional details are available on the THIOTEPA profile page.

The generic ingredient in THIOTEPA is thiotepa. There are ten 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 075547
Tradename:THIOTEPA
Applicant:West-ward Pharms Int
Ingredient:thiotepa
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075547
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 075547
Suppliers and Packaging for NDA: 075547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIOTEPA thiotepa INJECTABLE;INJECTION 075547 ANDA West-Ward Pharmaceuticals Corp 0143-9565 N 0143-9565-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/VIAL
Approval Date:Apr 2, 2001TE:APRLD:No

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