Application 008085

Type: NDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	METHOTREXATE SODIUM	METHOTREXATE SODIUM	TABLET;ORAL	EQ 2.5MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N008085-002	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL		RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008085-002	METHOTREXATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N008085-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N008085-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008085-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008085-002	AB	1	`ea99ee380514…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate Sodium	METHOTREXATE SODIUM	Elite Laboratories, Inc.	89c05ea3-3be1-46dd-b112-29c436fd7289	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate Sodium generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Sun Pharmaceutical Industries, Inc.	8f1260de-b60c-4f0e-8af6-0e957b0a281b	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate Sodium	METHOTREXATE SODIUM	Hikma Pharmaceuticals USA Inc.	d71b1856-99d8-4a9e-9189-f87b6675f80a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate Sodium generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ec476b11-0b3c-4139-b1eb-a3daa76bc271	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Bryant Ranch Prepack	c7592288-ac24-46c6-8cec-9abe23d7e81e	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	b585f621-f6c9-4735-ab61-bd1b401f3df0	2021-03-24	Boxed warning, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-110	METHOTREXATE	METHOTREXATE	Rebel Distributors Corp	NDA	Current
50090-0294	METHOTREXATE	METHOTREXATE	A-S Medication Solutions	NDA	Current
50090-0294	METHOTREXATE	METHOTREXATE	A-S Medication Solutions	NDA	Current
66336-338	METHOTREXATE	METHOTREXATE	Dispensing Solutions, Inc.	NDA	Current
67253-320	METHOTREXATE	METHOTREXATE	Par Pharmaceutical	NDA	Current
67253-320	METHOTREXATE	METHOTREXATE	Par Pharmaceutical, Inc.	NDA	Current
70518-0223	METHOTREXATE	METHOTREXATE	REMEDYREPACK INC.	NDA	Current
70518-0223	METHOTREXATE	METHOTREXATE	REMEDYREPACK INC.	NDA	Current
70518-0223	METHOTREXATE	METHOTREXATE	REMEDYREPACK INC.	NDA	Current
75840-111	METHOTREXATE SODIUM	METHOTREXATE SODIUM	GenPak Solutions LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62824	SUPPL	2020-05-05
62817	SUPPL	2020-05-05
53061	SUPPL	2018-03-20
53042	SUPPL	2018-03-16
32958	SUPPL	2016-02-18
142	SUPPL	2016-02-01
141	SUPPL	2006-06-02
32957	SUPPL	2003-11-05
32956	SUPPL	2003-11-05
91	SUPPL	2003-11-05
89	SUPPL	2003-11-05
140	SUPPL	2002-02-20
90	SUPPL	2002-02-20