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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Argus Health
Federal Trade Commission
Queensland Health

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074983

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

Summary for NDA: 074983

Formulation / Manufacturing:see details

Pharmacology for NDA: 074983

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 074983

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 074983 ANDA Fresenius Kabi USA, LLC 63323-104 63323-104-05 10 BOX in 1 CARTON (63323-104-05) > 1 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE
INJECTABLE;INJECTION 074983 ANDA Fresenius Kabi USA, LLC 63323-104 63323-104-25 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) > 25 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Express Scripts
Daiichi Sankyo
Federal Trade Commission

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