Application Information

This drug has been submitted to the FDA under the reference 040385/001.

Names and composition

"TREXALL" is the commercial name of a drug composed of METHOTREXATE SODIUM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
040385/001 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 5MG BASE
040385/002 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 7.5MG BASE
040385/003 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 10MG BASE
040385/004 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 15MG BASE

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
008085/002 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
011719/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per VIAL
011719/003 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
011719/004 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5MG BASE per ML
011719/005 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
011719/006 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
011719/007 METHOTREXATE LPF METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
011719/009 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
011719/010 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
011719/011 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5GM BASE per 100ML (EQ 25MG BASE per ML)
011719/012 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
011719/013 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 500MG BASE per 20ML (EQ 25MG BASE per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
011719/014 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per 2ML (EQ 10MG BASE per ML)
040054/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
040233/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
040263/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
040263/002 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
040265/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
040266/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
040385/001 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 5MG BASE
040385/002 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 7.5MG BASE
040385/003 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 10MG BASE
040385/004 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 15MG BASE
040632/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
040716/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
040767/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
040768/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
040843/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
040850/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
040853/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG per 10ML (EQ 25MG BASE per ML)
081099/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
081235/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
081242/001 FOLEX PFS METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
086358/001 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per VIAL
086358/002 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
086358/003 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
086358/004 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per VIAL
087695/001 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per VIAL
087695/002 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
087695/003 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
088648/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
088760/001 MEXATE-AQ METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
088935/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per VIAL
088936/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
088937/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
088954/001 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per VIAL
089158/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089161/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089180/001 FOLEX PFS METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089263/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089293/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 20MG BASE per VIAL
089294/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 50MG BASE per VIAL
089295/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 100MG BASE per VIAL
089296/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 250MG BASE per VIAL
089308/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 25MG BASE per ML
089309/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 25MG BASE per ML
089322/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089323/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5MG BASE per ML
089340/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
089341/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)
089342/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 200MG BASE per 8ML (EQ 25MG BASE per ML)
089343/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
089354/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
089355/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
089356/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per VIAL
089887/001 MEXATE-AQ PRESERVED METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
090029/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
090039/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
090039/002 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
200171/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)
201529/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
201529/002 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)
201529/003 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 200MG BASE per 8ML (EQ 25MG BASE per ML)
201529/004 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
201530/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
201749/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
207812/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
208400/001 XATMEP METHOTREXATE SODIUM SOLUTION/ORAL EQ 2.5MG BASE per ML

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