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Details for New Drug Application (NDA): 074529

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NDA 074529 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: 074529

Tradename:
ETOPOSIDE
Applicant:
Teva Pharms Usa
Ingredient:
etoposide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 074529

Mechanism of ActionTopoisomerase Inhibitors

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

Summary for product number 001

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


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