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Details for New Drug Application (NDA): 020326

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NDA 020326 describes NEUTREXIN, which is a drug marketed by Medimmune Oncology and is included in one NDA. There is one patent protecting this drug. Additional details are available on the NEUTREXIN profile page.

The generic ingredient in NEUTREXIN is trimetrexate glucuronate. There is one drug master file entry for this compound. Additional details are available on the trimetrexate glucuronate profile page.

Summary for NDA: 020326

Tradename:
NEUTREXIN
Applicant:
Medimmune Oncology
Ingredient:
trimetrexate glucuronate
Patents:1
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/VIAL
Approval Date:Dec 17, 1993TE:RLD:No
Patent:6,017,922Patent Expiration:May 18, 2018Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Jul 31, 1998TE:RLD:No
Patent:6,017,922Patent Expiration:May 18, 2018Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020326

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimmune Oncology
NEUTREXIN
trimetrexate glucuronate
INJECTABLE;INJECTION020326-001Dec 17, 19934,376,858► subscribe
Medimmune Oncology
NEUTREXIN
trimetrexate glucuronate
INJECTABLE;INJECTION020326-001Dec 17, 19934,694,007► subscribe
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