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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

Tradename:
ETOPOPHOS PRESERVATIVE FREE
Applicant:
Bristol Myers Squibb
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

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
ETOPOPHOS PRESERVATIVE FREE
etoposide phosphate
INJECTABLE;INJECTION020457-001May 17, 19965,041,424► subscribe
Bristol Myers Squibb
ETOPOPHOS PRESERVATIVE FREE
etoposide phosphate
INJECTABLE;INJECTION020457-001May 17, 1996RE35524► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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