Home Applications 203568 Application 203568
Type NDA
Sponsor KASTLE THERAPS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KYNAMRO MIPOMERSEN SODIUM SOLUTION;SUBCUTANEOUS 200MG/ML (200MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N203568-001 KYNAMRO MIPOMERSEN SODIUM 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203568-001 7511131 2027-01-29 Drug substance
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 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203568-001 KYNAMRO 200MG/ML (200MG/ML) SOLUTION / SUBCUTANEOUS RLD 2013-01-29 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 100 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N203568-001 7511131 2027-01-29 Drug substance 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203568-001 7511131 2027-01-29 Drug substance caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203568-001 7511131 2027-01-29 Drug substance 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203568-001 7511131 2027-01-29 Drug substance 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203568-001 7511131 2027-01-29 Drug substance 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203568-001 7511131 2027-01-29 Drug substance fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203568-001 7511131 2027-01-29 Drug substance b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203568-001 7511131 2027-01-29 Drug substance 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203568-001 7511131 2027-01-29 Drug substance 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203568-001 7511131 2027-01-29 Drug substance 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203568-001 7511131 2027-01-29 Drug substance d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203568-001 7511131 2027-01-29 Drug substance d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203568-001 7511131 2027-01-29 Drug substance 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203568-001 7511131 2027-01-29 Drug substance 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203568-001 7511131 2027-01-29 Drug substance 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203568-001 7511131 2027-01-29 Drug substance 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 7015315 2023-03-21 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 7101993 2023-09-05 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203568-001 7511131 2027-01-29 Drug substance 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203568-001 7015315 2023-03-21 Drug substance 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203568-001 7101993 2023-09-05 Drug substance 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203568-001 7511131 2027-01-29 Drug substance 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203568-001 7015315 2023-03-21 Drug substance 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203568-001 7101993 2023-09-05 Drug substance 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203568-001 7511131 2027-01-29 Drug substance 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203568-001 7407943 2021-08-01 U-1353 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203568-001 7015315 2023-03-21 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203568-001 7101993 2023-09-05 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203568-001 7511131 2027-01-29 Drug substance 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203568-001 7015315 2023-03-21 Drug substance bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203568-001 7101993 2023-09-05 Drug substance bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203568-001 7511131 2027-01-29 Drug substance bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203568-001 7407943 2021-08-01 U-1353 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203568-001 7015315 2023-03-21 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203568-001 7101993 2023-09-05 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203568-001 7511131 2027-01-29 Drug substance 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7407943 2021-08-01 U-1353 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7015315 2023-03-21 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7101993 2023-09-05 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203568-001 7511131 2027-01-29 Drug substance 87673890dc5c…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70688-0502 Kynamro MIPOMERSEN SODIUM Kastle Therapeutics, LLC NDA Current