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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A040385-001	TREXALL	METHOTREXATE SODIUM	EQ 5MG BASE	TABLET / ORAL		2001-03-21
A040385-002	TREXALL	METHOTREXATE SODIUM	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21
A040385-003	TREXALL	METHOTREXATE SODIUM	EQ 10MG BASE	TABLET / ORAL		2001-03-21
A040385-004	TREXALL	METHOTREXATE SODIUM	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040385-001	TREXALL	EQ 5MG BASE	TABLET / ORAL		2001-03-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040385-002	TREXALL	EQ 7.5MG BASE	TABLET / ORAL		2001-03-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040385-003	TREXALL	EQ 10MG BASE	TABLET / ORAL		2001-03-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040385-004	TREXALL	EQ 15MG BASE	TABLET / ORAL	RS	2001-03-21	`6a51e52b5d6a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trexall	METHOTREXATE	Teva Women's Health LLC	e942f8db-510f-44d6-acb5-b822196f5e8c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040385 application number: ANDA040385 ndc (product): 51285-369 ndc (product): 51285-368 ndc (product): 51285-367 ndc (product): 51285-366

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

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