Application 212479

Type: NDA
Sponsor: THERAKIND LIMITED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JYLAMVO	METHOTREXATE	SOLUTION;ORAL	2MG/ML	No	No
002	JYLAMVO	METHOTREXATE	SOLUTION;ORAL	2MG/ML	No	No
003	JYLAMVO	METHOTREXATE	SUSPENSION;ORAL	2MG/ML	No	No
004	JYLAMVO	METHOTREXATE	SOLUTION;ORAL	2MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
N212479-001	JYLAMVO	METHOTREXATE	2MG/ML	SOLUTION / ORAL		RLD, RS	2022-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20
N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20
N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20
N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20
N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20
N212479-001	12605385	2035-10-25		Drug product	2026-05-15
N212479-001	11129833	2035-10-28		Drug product	2023-08-22

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
2026-11-14 07:37:17	2026-10	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD	2022-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD	2022-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD	2022-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212479-001	JYLAMVO	2MG/ML	SOLUTION / ORAL	RLD, RS	2022-11-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N212479-001	12605385	2035-10-25		Drug product	2026-05-15	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N212479-001	11129833	2035-10-28		Drug product	2023-08-22	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212479-001	12605385	2035-10-25		Drug product	2026-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212479-001	11129833	2035-10-28		Drug product	2023-08-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212479-001	12605385	2035-10-25		Drug product	2026-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212479-001	11129833	2035-10-28		Drug product	2023-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212479-001	12605385	2035-10-25		Drug product	2026-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212479-001	11129833	2035-10-28		Drug product	2023-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212479-001	11129833	2035-10-28		Drug product	2023-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	11771701	2034-10-29	U-3700	Drug product	2023-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	11771701	2034-10-29	U-3701	Drug product	2023-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	11771701	2034-10-29	U-3702	Drug product	2023-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	11771701	2034-10-29	U-3703	Drug product	2023-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	11771701	2034-10-29	U-3704	Drug product	2023-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212479-001	11129833	2035-10-28		Drug product	2023-08-22	`31067a03dcf5…`

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Safecor Health LLC	f177e6fa-c482-432d-8208-937468ab3f10	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	AvPAK	4992fdaa-b880-ee25-e063-6394a90af03b	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Chartwell RX, LLC	2609da8f-80dc-448e-8eba-35d11488ce7f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Rasuvo	METHOTREXATE	Medexus Pharma Inc.	d0075461-0e7e-4967-9c9b-d6440e912c0e	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Mylan Institutional Inc.	8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hikma Pharmaceuticals USA Inc.	b080eb92-fc72-4ce6-a7ab-3f9ce2415526	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Teva Parenteral Medicines, Inc.	346ec9ce-dc98-4a55-b55e-d3af11f2d703	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Eugia US LLC	63bb6fbf-dd59-4edc-af8f-d0c397ca1262	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Coupler LLC	2f20d43e-a4b3-a839-e063-6394a90ace38	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Otrexup	METHOTREXATE	Antares Pharma, Inc.	9ab8ce16-f7de-41d4-a4c8-1c742621b6d5	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	2b61822e-b488-5eaf-e063-6394a90a2dcd	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Zydus Lifesciences Limited	59ea7b32-2b6d-4197-92c3-015936f04ebe	2024-12-05		Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	e6611304-4622-4b2e-9b94-57fbad023ae2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hikma Pharmaceuticals USA Inc.	8593f7fc-eabe-44ae-bb05-b3d7d408e4f7	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Proficient Rx LP	a76808f0-38a7-4b54-a4fb-3584f9058ae5	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Limited	ff55c573-dc84-4ff3-9d10-2b24c47dd679	2024-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hikma Pharmaceuticals USA Inc.	3989d30d-56e5-4e8d-9379-c30fecc894f2	2023-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79978	SUPPL	2024-10-25
79977	SUPPL	2024-10-25
79973	SUPPL	2024-10-24
79972	SUPPL	2024-10-24
75097	ORIG	2023-08-17
75096	ORIG	2023-08-17
75095	ORIG	2023-08-17
75094	ORIG	2023-08-17
72769	ORIG	2022-12-02
72768	ORIG	2022-12-02
72767	ORIG	2022-12-02
72766	ORIG	2022-12-02
72755	ORIG	2022-11-30
72754	ORIG	2022-11-30
72753	ORIG	2022-11-30
72752	ORIG	2022-11-30