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Last Updated: November 18, 2019

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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 Cheplapharm 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 020457
Tradename:ETOPOPHOS PRESERVATIVE FREE
Applicant:Cheplapharm
Ingredient:etoposide phosphate
Patents:0
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
ETOPOPHOS PRESERVATIVE FREE 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

Profile for product number 001

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

Expired US Patents for NDA 020457

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020457-001 May 17, 1996   Start Trial   Start Trial
Cheplapharm ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020457-001 May 17, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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