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Generated: May 23, 2017

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Details for New Drug Application (NDA): 020457

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NDA 020457 describes ETOPOPHOS PRESERVATIVE FREE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the ETOPOPHOS PRESERVATIVE FREE profile page.

The generic ingredient in ETOPOPHOS PRESERVATIVE FREE is etoposide phosphate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etoposide phosphate profile page.

Summary for NDA: 020457

Formulation / Manufacturing:see details

Pharmacology for NDA: 020457

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 020457

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
etoposide phosphate
INJECTABLE;INJECTION 020457 NDA E.R. Squibb & Sons, L.L.C. 0015-3404 0015-3404-20 1 VIAL, SINGLE-DOSE in 1 CARTON (0015-3404-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:May 17, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020457

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
etoposide phosphate
INJECTABLE;INJECTION020457-001May 17, 19965,041,424► Subscribe
Bristol Myers Squibb
etoposide phosphate
INJECTABLE;INJECTION020457-001May 17, 1996RE35524► Subscribe
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