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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Queensland Health

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074529

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NDA 074529 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 fourteen 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 074529
Applicant:Teva Pharms Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 074529
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 074529
Suppliers and Packaging for NDA: 074529
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETOPOSIDE etoposide INJECTABLE;INJECTION 074529 ANDA Teva Parenteral Medicines, Inc. 0703-5653 0703-5653-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-5653-01) > 5 mL in 1 VIAL, MULTI-DOSE
ETOPOSIDE etoposide INJECTABLE;INJECTION 074529 ANDA Teva Parenteral Medicines, Inc. 0703-5656 0703-5656-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-5656-01) > 25 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Jul 24, 1996TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission

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