Application 207812

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	TABLET;ORAL	EQ 2.5MG BASE	No	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
A207812-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		2017-01-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207812-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207812-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207812-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207812-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207812-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207812-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207812-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207812-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207812-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207812-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207812-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207812-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207812-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207812-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207812-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207812-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207812-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207812-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207812-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207812-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207812-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207812-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207812-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207812-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207812-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207812-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207812-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207812-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207812-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207812-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207812-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207812-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207812-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207812-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207812-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207812-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207812-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207812-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207812-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207812-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207812-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Major Pharmaceuticals	2a6afc4c-819d-4ba9-8040-4504519c116a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207812 application number: ANDA207812 ndc (product): 0904-7141
Methotrexate	METHOTREXATE	Zydus Pharmaceuticals USA Inc.	948e0bab-6524-4b87-9853-1799d4415558	2026-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207812 application number: ANDA207812 ndc (product): 68382-775
Methotrexate	METHOTREXATE	AvPAK	4992fdaa-b880-ee25-e063-6394a90af03b	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207812 application number: ANDA207812
Methotrexate	METHOTREXATE	Zydus Lifesciences Limited	59ea7b32-2b6d-4197-92c3-015936f04ebe	2024-12-05		Exact identifier application applno (ANDA): 207812 application number: ANDA207812 ndc (product): 70771-1058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7141	Methotrexate	Methotrexate	Major Pharmaceuticals	ANDA	Current
0904-7141	Methotrexate	Methotrexate	Major Pharmaceuticals	ANDA	Current
68382-775	Methotrexate	Methotrexate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-775	Methotrexate	Methotrexate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-775	Methotrexate	Methotrexate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-775	Methotrexate	Methotrexate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-775	Methotrexate	Methotrexate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-1398	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70771-1058	Methotrexate	Methotrexate	Zydus Lifesciences Limited	ANDA	Current
70771-1058	Methotrexate	Methotrexate	Cadila Healthcare Limited	ANDA	Current
70771-1058	Methotrexate	Methotrexate	Cadila Healthcare Limited	ANDA	Current
70771-1058	Methotrexate	Methotrexate	Cadila Healthcare Limited	ANDA	Current