Home Applications 212479 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 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 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 Product TE source text RLD / RS Approval date Source SHA-256 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 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3703 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11771701 2034-10-29 U-3704 Drug product 2023-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212479-001 11129833 2035-10-28 Drug product 2023-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 11771701 2034-10-29 U-3700 Drug product 2023-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 11771701 2034-10-29 U-3701 Drug product 2023-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212479-001 11771701 2034-10-29 U-3702 Drug product 2023-10-20 03ed91905a0d…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join JYLAMVO METHOTREXATE SHORLA ONCOLOGY INC. 96e931f5-51ae-4bdf-a441-bb0dd26d4c0e 2026-06-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212479 application number: NDA212479