Application 205353

Type
NDA
Sponsor
SECURA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FARYDAKPANOBINOSTAT LACTATECAPSULE;ORALEQ 10MG BASEYesNo
002FARYDAKPANOBINOSTAT LACTATECAPSULE;ORALEQ 15MG BASEYesNo
003FARYDAKPANOBINOSTAT LACTATECAPSULE;ORALEQ 20MG BASEYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205353-001FARYDAKPANOBINOSTAT LACTATEEQ 10MG BASECAPSULE / ORALRLD2015-02-23
N205353-002FARYDAKPANOBINOSTAT LACTATEEQ 15MG BASECAPSULE / ORALRLD2015-02-23
N205353-003FARYDAKPANOBINOSTAT LACTATEEQ 20MG BASECAPSULE / ORALRLD2015-02-23

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205353-00179894942028-01-17Drug substance, Drug product2015-03-20
N205353-00188838422028-06-13U-16692015-03-20
N205353-00279894942028-01-17Drug substance, Drug product2015-03-20
N205353-00288838422028-06-13U-16692015-03-20
N205353-00379894942028-01-17Drug substance, Drug product2015-03-20
N205353-00388838422028-06-13U-16692015-03-20

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2020-11-12 02:37 UTC2020-11N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD, RS2015-02-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-233f01610625f2…
2019-12-14 00:12 UTC2019-12N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD, RS2015-02-233f01610625f2…
2019-09-15 20:21 UTC2019-09N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD, RS2015-02-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD, RS2015-02-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-231c564ffb4f44…
2024-02-18 07:12 UTC2024-02N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-231c564ffb4f44…
2024-02-18 07:12 UTC2024-02N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-23ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-23ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-23a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-23a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-239b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-239b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-23a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-23a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-233f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-233f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-23053a50430f4f…
2023-05-13 08:27 UTC2023-05N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-23053a50430f4f…
2023-05-13 08:27 UTC2023-05N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-233bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-233bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205353-001FARYDAKEQ 10MG BASECAPSULE / ORALRLD2015-02-233a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205353-002FARYDAKEQ 15MG BASECAPSULE / ORALRLD2015-02-233a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205353-003FARYDAKEQ 20MG BASECAPSULE / ORALRLD2015-02-233a93d1ddd44b…

Observed Orange Book patent history#

Patent history page 1 of 9 · 345 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N205353-00179894942028-01-17Drug substance, Drug product2015-03-20c2088c7a36db…
2026-10-15 13:18:302026-09N205353-00188838422028-06-13U-16692015-03-20c2088c7a36db…
2026-10-15 13:18:302026-09N205353-00279894942028-01-17Drug substance, Drug product2015-03-20c2088c7a36db…
2026-10-15 13:18:302026-09N205353-00288838422028-06-13U-16692015-03-20c2088c7a36db…
2026-10-15 13:18:302026-09N205353-00379894942028-01-17Drug substance, Drug product2015-03-20c2088c7a36db…
2026-10-15 13:18:302026-09N205353-00388838422028-06-13U-16692015-03-20c2088c7a36db…
2026-09-14 22:38:342026-08N205353-00179894942028-01-17Drug substance, Drug product2015-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N205353-00188838422028-06-13U-16692015-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N205353-00279894942028-01-17Drug substance, Drug product2015-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N205353-00288838422028-06-13U-16692015-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N205353-00379894942028-01-17Drug substance, Drug product2015-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N205353-00388838422028-06-13U-16692015-03-2084e616aacf4f…
2026-08-18 06:07:402026-07N205353-00179894942028-01-17Drug substance, Drug product2015-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205353-00188838422028-06-13U-16692015-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205353-00279894942028-01-17Drug substance, Drug product2015-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205353-00288838422028-06-13U-16692015-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205353-00379894942028-01-17Drug substance, Drug product2015-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205353-00388838422028-06-13U-16692015-03-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205353-00179894942028-01-17Drug substance, Drug product2015-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205353-00188838422028-06-13U-16692015-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205353-00279894942028-01-17Drug substance, Drug product2015-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205353-00288838422028-06-13U-16692015-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205353-00379894942028-01-17Drug substance, Drug product2015-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205353-00388838422028-06-13U-16692015-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205353-00179894942028-01-17Drug substance, Drug product2015-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205353-00188838422028-06-13U-16692015-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205353-00279894942028-01-17Drug substance, Drug product2015-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205353-00288838422028-06-13U-16692015-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205353-00379894942028-01-17Drug substance, Drug product2015-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205353-00388838422028-06-13U-16692015-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N205353-00179894942028-01-17Drug substance, Drug product2015-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205353-00188838422028-06-13U-16692015-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205353-00279894942028-01-17Drug substance, Drug product2015-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205353-00288838422028-06-13U-16692015-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205353-00379894942028-01-17Drug substance, Drug product2015-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205353-00388838422028-06-13U-16692015-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205353-00179894942028-01-17Drug substance, Drug product2015-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205353-00188838422028-06-13U-16692015-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205353-00279894942028-01-17Drug substance, Drug product2015-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205353-00288838422028-06-13U-16692015-03-20fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205353-001ODE-892022-02-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205353-002ODE-892022-02-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205353-003ODE-892022-02-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205353-001ODE-892022-02-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205353-002ODE-892022-02-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205353-003ODE-892022-02-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205353-001ODE-892022-02-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205353-002ODE-892022-02-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205353-003ODE-892022-02-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205353-001NCE2020-02-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205353-001ODE-892022-02-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205353-002NCE2020-02-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205353-002ODE-892022-02-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205353-003NCE2020-02-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205353-003ODE-892022-02-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205353-001ODE-892022-02-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N205353-002ODE-892022-02-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N205353-003ODE-892022-02-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205353-001ODE-892022-02-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N205353-002ODE-892022-02-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N205353-003ODE-892022-02-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205353-001ODE-892022-02-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205353-002ODE-892022-02-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205353-003ODE-892022-02-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N205353-001ODE-892022-02-235aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N205353-002ODE-892022-02-235aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N205353-003ODE-892022-02-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205353-001NCE2020-02-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205353-001ODE-892022-02-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205353-002NCE2020-02-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205353-002ODE-892022-02-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205353-003NCE2020-02-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205353-003ODE-892022-02-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205353-001NCE2020-02-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205353-001ODE-892022-02-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205353-002NCE2020-02-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205353-002ODE-892022-02-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205353-003NCE2020-02-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205353-003ODE-892022-02-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205353-001NCE2020-02-233f01610625f2…

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0650FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0650FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0650FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0650FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0650FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0651FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0651FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0651FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0651FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0652FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0652FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0652FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0652FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
0078-0652FARYDAKpanobinostatNovartis Pharmaceuticals CorporationNDACurrent
73116-100FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-100FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-100FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-101FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-101FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-101FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-102FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-102FARYDAKpanobinostatSecura Bio, Inc.NDACurrent
73116-102FARYDAKpanobinostatSecura Bio, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32661SUPPL2016-06-08
24491ORIG2015-03-17
22983ORIG2015-03-17
23519ORIG2015-03-03
24126ORIG2015-02-25
32660ORIG2015-02-24
40463ORIG2015-02-23