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US Department of Justice
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Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074983

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NDA 074983 describes ETOPOSIDE, which is a drug marketed by Mylan, Accord Hlthcare, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Pharmachemie Bv, Pierre Fabre, Teva Parenteral, Teva Pharms Usa, Watson Labs, Watson Labs Inc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from six suppliers. Additional details are available on the ETOPOSIDE profile page.

The generic ingredient in ETOPOSIDE is etoposide. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the etoposide profile page.
Summary for 074983
Applicant:Fresenius Kabi Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 074983
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 074983
Suppliers and Packaging for NDA: 074983
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETOPOSIDE etoposide INJECTABLE;INJECTION 074983 ANDA Fresenius Kabi USA, LLC 63323-104 N 63323-104-05
ETOPOSIDE etoposide INJECTABLE;INJECTION 074983 ANDA Fresenius Kabi USA, LLC 63323-104 N 63323-104-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Sep 30, 1998TE:APRLD:No

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Queensland Health
Harvard Business School
US Army

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