Application 203407

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	No	No
002	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	No	No
003	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09
A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09
A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203407-001	AP
A203407-002	AP
A203407-003	AP

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 4 · 126 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	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203407-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203407-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203407-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2018-08-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A203407-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203407-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203407-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203407-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203407-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203407-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203407-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203407-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203407-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203407-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203407-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203407-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203407-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203407-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203407-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203407-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203407-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203407-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203407-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203407-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203407-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203407-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203407-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203407-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203407-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203407-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203407-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203407-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203407-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203407-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203407-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203407-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203407-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203407-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203407-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203407-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203407-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203407-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203407-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203407-001	AP	1	`1e350fbaab3a…`

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 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 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