Application 040385

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TREXALL	METHOTREXATE SODIUM	TABLET;ORAL	EQ 5MG BASE	No	No
002	TREXALL	METHOTREXATE SODIUM	TABLET;ORAL	EQ 7.5MG BASE	No	No
003	TREXALL	METHOTREXATE SODIUM	TABLET;ORAL	EQ 10MG BASE	No	No
004	TREXALL	METHOTREXATE SODIUM	TABLET;ORAL	EQ 15MG BASE	No	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51285-366	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-366	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-366	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-366	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-366	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-366	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-367	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-367	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-367	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-367	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-367	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-367	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-368	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-368	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-368	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-368	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-368	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-368	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-369	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-369	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-369	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-369	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-369	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current
51285-369	Trexall	Methotrexate	Teva Women's Health, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42623	ORIG	2007-03-31
7642	ORIG	2001-03-21

Application 040385

Related Records#

Application Products#

NDC Listings For This Application#

Documents#