Application 211172

Type
NDA
Sponsor
AKCEA THERAPS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEGSEDIINOTERSEN SODIUMSOLUTION;SUBCUTANEOUSEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211172-001TEGSEDIINOTERSEN SODIUMEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211172-00186978602031-04-29Drug product2018-11-01
N211172-00190610442031-04-29Drug substance2018-11-01
N211172-00193997742031-04-29U-24302018-11-01

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05c2088c7a36db…
2026-09-14 22:38:342026-08N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-0584e616aacf4f…
2026-08-18 06:07:402026-07N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2018-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-053f01610625f2…
2019-09-15 20:21 UTC2019-09N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211172-001TEGSEDIEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-10-053a93d1ddd44b…

Observed Orange Book patent history#

Patent history page 1 of 6 · 219 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N211172-00186978602031-04-29Drug product2018-11-01c2088c7a36db…
2026-10-15 13:18:302026-09N211172-00190610442031-04-29Drug substance2018-11-01c2088c7a36db…
2026-10-15 13:18:302026-09N211172-00193997742031-04-29U-24302018-11-01c2088c7a36db…
2026-09-14 22:38:342026-08N211172-00186978602031-04-29Drug product2018-11-0184e616aacf4f…
2026-09-14 22:38:342026-08N211172-00190610442031-04-29Drug substance2018-11-0184e616aacf4f…
2026-09-14 22:38:342026-08N211172-00193997742031-04-29U-24302018-11-0184e616aacf4f…
2026-08-18 06:07:402026-07N211172-00186978602031-04-29Drug product2018-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07N211172-00190610442031-04-29Drug substance2018-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07N211172-00193997742031-04-29U-24302018-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211172-00186978602031-04-29Drug product2018-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211172-00190610442031-04-29Drug substance2018-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211172-00193997742031-04-29U-24302018-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211172-00181017432025-04-01Drug substance, Drug product2018-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211172-00186978602031-04-29Drug product2018-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211172-00190610442031-04-29Drug substance2018-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211172-00193997742031-04-29U-24302018-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N211172-00181017432025-04-01Drug substance, Drug product2018-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211172-00186978602031-04-29Drug product2018-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211172-00190610442031-04-29Drug substance2018-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211172-00193997742031-04-29U-24302018-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211172-00181017432025-04-01Drug substance, Drug product2018-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211172-00186978602031-04-29Drug product2018-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211172-00190610442031-04-29Drug substance2018-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211172-00193997742031-04-29U-24302018-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211172-00181017432025-04-01Drug substance, Drug product2018-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211172-00186978602031-04-29Drug product2018-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211172-00190610442031-04-29Drug substance2018-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211172-00193997742031-04-29U-24302018-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211172-00181017432025-04-01Drug substance, Drug product2018-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211172-00186978602031-04-29Drug product2018-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211172-00190610442031-04-29Drug substance2018-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211172-00193997742031-04-29U-24302018-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211172-00181017432025-04-01Drug substance, Drug product2018-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211172-00186978602031-04-29Drug product2018-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211172-00190610442031-04-29Drug substance2018-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211172-00193997742031-04-29U-24302018-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211172-00181017432025-04-01Drug substance, Drug product2018-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211172-00186978602031-04-29Drug product2018-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211172-00190610442031-04-29Drug substance2018-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211172-00193997742031-04-29U-24302018-11-015bbf6a4d5a75…

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2024-02-18 07:12 UTC2024-02N211172-001ODE-2122025-10-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211172-001NCE2023-10-05ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N211172-001ODE-2122025-10-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211172-001NCE2023-10-05a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211172-001ODE-2122025-10-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211172-001NCE2023-10-059b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211172-001ODE-2122025-10-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211172-001NCE2023-10-05a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211172-001ODE-2122025-10-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211172-001NCE2023-10-053f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211172-001ODE-2122025-10-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N211172-001NCE2023-10-05053a50430f4f…
2023-05-13 08:27 UTC2023-05N211172-001ODE-2122025-10-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N211172-001NCE2023-10-053bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N211172-001ODE-2122025-10-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211172-001NCE2023-10-053a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211172-001ODE-2122025-10-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211172-001NCE2023-10-05f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N211172-001ODE-2122025-10-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211172-001NCE2023-10-05e64feba35796…
2022-09-29 23:25 UTC2022-09N211172-001ODE-2122025-10-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211172-001NCE2023-10-05cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211172-001ODE-2122025-10-05cb3db0bc1861…

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent
72126-007TegsediinotersenAkcea Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80423SUPPL 2024-11-26
77224SUPPL 2024-01-16
77223SUPPL 2024-01-16
77220SUPPL 2024-01-16
76279ORIG 2023-11-03
73715SUPPL 2023-03-09
71428SUPPL2022-06-23
71415SUPPL2022-06-21
71414SUPPL2022-06-21
70679SUPPL2022-04-04
64169SUPPL2020-08-03
64168SUPPL2020-08-03
64153SUPPL2020-07-31
62946SUPPL2020-05-13
62908SUPPL2020-05-12
60697SUPPL2019-10-29
60687SUPPL2019-10-28
60686SUPPL2019-10-28
56222ORIG2018-11-01
56102APPL2018-10-26
55894ORIG2018-10-11
55851ORIG2018-10-05
55850ORIG2018-10-05