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Details for New Drug Application (NDA): 078408

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NDA 078408 describes VINORELBINE TARTRATE, which is a drug marketed by Jiangsu Hansoh Pharm, Ebewe Pharma, Actavis Totowa, Dr Reddys Labs Ltd, Hospira, Teva Pharms Usa, Mylan Labs Ltd, Fresenius Kabi Usa, and Eurohlth Intl Sarl, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the VINORELBINE TARTRATE profile page.

The generic ingredient in VINORELBINE TARTRATE is vinorelbine tartrate. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.

Summary for NDA: 078408

Ebewe Pharma
vinorelbine tartrate

Pharmacology for NDA: 078408

Ingredient-typeVinca Alkaloids

Suppliers and Packaging for NDA: 078408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vinorelbine tartrate
INJECTABLE;INJECTION 078408 ANDA Sandoz Inc. 66758-045 66758-045-01 1 VIAL, SINGLE-DOSE in 1 CARTON (66758-045-01) > 1 mL in 1 VIAL, SINGLE-DOSE
vinorelbine tartrate
INJECTABLE;INJECTION 078408 ANDA Sandoz Inc. 66758-045 66758-045-02 1 VIAL, SINGLE-DOSE in 1 CARTON (66758-045-02) > 5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Approval Date:Feb 13, 2008TE:RLD:No

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