Application 214121

Type: NDA
Sponsor: ACCORD HLTHCARE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE	METHOTREXATE	INJECTABLE;INJECTION	5G/50ML	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
N214121-001	METHOTREXATE	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-08-24

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	AvKARE	757d6cef-6696-7a1c-8074-01258aaa8bdd	2026-07-23	Boxed warning, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Trexall	METHOTREXATE	Teva Women's Health LLC	e942f8db-510f-44d6-acb5-b822196f5e8c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	b6e61c50-024a-494f-b04c-100fb371a837	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
JYLAMVO	METHOTREXATE	SHORLA ONCOLOGY INC.	96e931f5-51ae-4bdf-a441-bb0dd26d4c0e	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Teva Pharmaceuticals USA, Inc.	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Major Pharmaceuticals	2a6afc4c-819d-4ba9-8040-4504519c116a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Xatmep	METHOTREXATE	Azurity Pharmaceuticals, Inc.	aec9984e-34c5-481b-b6bf-9bb5caf1daf8	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Accord Healthcare Inc.	874c7f43-a3be-4236-89cc-24c44e3c5813	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Bryant Ranch Prepack	4a04756f-e1c9-4d1e-b309-7be31c9176d6	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHOTREXATE generic name: METHOTREXATE
Methotrexate	METHOTREXATE SODIUM	Sun Pharmaceutical Industries, Inc.	8f1260de-b60c-4f0e-8af6-0e957b0a281b	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	4741a44f-0d0b-4380-84f6-231a8d1560fb	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Inc.	04a95db9-a124-4b97-bd71-1c37a6b3b0c8	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHOTREXATE generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Zydus Pharmaceuticals USA Inc.	948e0bab-6524-4b87-9853-1799d4415558	2026-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Mylan Pharmaceuticals Inc.	70c09984-2b36-424f-8b27-3fd0cd4e833d	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Aurobindo Pharma Limited	09931d44-a3f8-49dc-a3f2-b527ee4214bf	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	50b2cfc7-dfe4-4406-e063-6294a90a2527	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Inc.	a63364d5-4dfa-49d7-8a5e-c8959ae1d37a	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHOTREXATE generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Limited	e98b2abd-8068-482e-9ce3-1ab262f0838e	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHOTREXATE generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Golden State Medical Supply, Inc.	6f14ced9-c16b-905a-e053-2a91aa0a031e	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85383	SUPPL	2026-03-16
85391	SUPPL	2026-03-12
82432	SUPPL	2025-06-02
82431	SUPPL	2025-06-02
79594	SUPPL	2024-09-16
70530	SUPPL	2022-03-16
70484	SUPPL	2022-03-11
65389	ORIG	2020-11-30
64413	ORIG	2020-08-25