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Generated: November 18, 2018

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Details for New Drug Application (NDA): 040385

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NDA 040385 describes TREXALL, which is a drug marketed by Barr and is included in one NDA. It is available from one supplier. Additional details are available on the TREXALL profile page.

The generic ingredient in TREXALL is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 040385
Tradename:TREXALL
Applicant:Barr
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040385
Suppliers and Packaging for NDA: 040385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TREXALL methotrexate sodium TABLET;ORAL 040385 ANDA Teva Women's Health, Inc. 51285-366 51285-366-01 30 TABLET, FILM COATED in 1 BOTTLE (51285-366-01)
TREXALL methotrexate sodium TABLET;ORAL 040385 ANDA Teva Women's Health, Inc. 51285-367 51285-367-01 30 TABLET, FILM COATED in 1 BOTTLE (51285-367-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Mar 21, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 7.5MG BASE
Approval Date:Mar 21, 2001TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 21, 2001TE:RLD:No

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