Details for New Drug Application (NDA): 040385

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 is one drug master file entry for this compound. Thirty 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

Pharmacology for NDA: 040385

Mechanism of Action

Folic Acid Metabolism Inhibitors

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 LLC	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 LLC	51285-367	51285-367-01	30 TABLET, FILM COATED in 1 BOTTLE (51285-367-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Mar 21, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Mar 21, 2001	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Mar 21, 2001	TE:		RLD:	No

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