Application 217552

Type: ANDA
Sponsor: ALEMBIC

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 1.

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
A217552-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		2024-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217552-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217552-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2024-06-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217552-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217552-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217552-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217552-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217552-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217552-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217552-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217552-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217552-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217552-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217552-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217552-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217552-001	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217552-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHOTREXATE	METHOTREXATE	Bryant Ranch Prepack	4a04756f-e1c9-4d1e-b309-7be31c9176d6	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217552 application number: ANDA217552
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Inc.	04a95db9-a124-4b97-bd71-1c37a6b3b0c8	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217552 application number: ANDA217552
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Limited	ff55c573-dc84-4ff3-9d10-2b24c47dd679	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217552 application number: ANDA217552