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Boehringer Ingelheim

Last Updated: February 24, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210337

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NDA 210337 describes THIOTEPA, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Immunex, Jiangsu Hengrui Med, Sti Pharma Llc, Teva Parenteral, and West-ward Pharms Int, and is included in seven 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 210337
Applicant:Dr Reddys
Formulation / Manufacturing:see details
Pharmacology for NDA: 210337
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 210337
Suppliers and Packaging for NDA: 210337
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIOTEPA thiotepa INJECTABLE;INJECTION 210337 ANDA Dr.Reddy's Laboratories Inc., 43598-650 43598-650-11 1 VIAL in 1 CARTON (43598-650-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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