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 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Accord Healthcare, Inc.	dd035a9f-cd40-4314-b9d8-2294b8a924e2	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	A-S Medication Solutions	22e10810-16fb-4c84-bccf-972405b77ef8	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	AvKARE	757d6cef-6696-7a1c-8074-01258aaa8bdd	2026-07-23	Boxed warning, Adverse reactions	Name fallback 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 generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Teva Pharmaceuticals USA, Inc.	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Major Pharmaceuticals	2a6afc4c-819d-4ba9-8040-4504519c116a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback 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 generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Bryant Ranch Prepack	4a04756f-e1c9-4d1e-b309-7be31c9176d6	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	4741a44f-0d0b-4380-84f6-231a8d1560fb	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Inc.	04a95db9-a124-4b97-bd71-1c37a6b3b0c8	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Zydus Pharmaceuticals USA Inc.	948e0bab-6524-4b87-9853-1799d4415558	2026-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Mylan Pharmaceuticals Inc.	70c09984-2b36-424f-8b27-3fd0cd4e833d	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Aurobindo Pharma Limited	09931d44-a3f8-49dc-a3f2-b527ee4214bf	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	50b2cfc7-dfe4-4406-e063-6294a90a2527	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Inc.	a63364d5-4dfa-49d7-8a5e-c8959ae1d37a	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Limited	e98b2abd-8068-482e-9ce3-1ab262f0838e	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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