Application 207999

Type
NDA
Sponsor
INTERCEPT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCALIVAOBETICHOLIC ACIDTABLET;ORAL5MGYesNo
002OCALIVAOBETICHOLIC ACIDTABLET;ORAL10MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207999-001OCALIVAOBETICHOLIC ACID5MGTABLET / ORALRLD2016-05-27
N207999-002OCALIVAOBETICHOLIC ACID10MGTABLET / ORALRLD2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207999-001RE482862027-02-21Drug substance, Drug product2020-10-28
N207999-001101740732033-06-17Drug substance2019-01-15
N207999-00192386732033-06-17Drug product2016-06-22
N207999-001100471172033-09-06U-18542018-11-14
N207999-001100523372036-04-26Drug product2018-11-08
N207999-001107513492036-04-26Drug product2020-08-28
N207999-001107585492036-04-26U-29452020-09-10
N207999-002RE482862027-02-21Drug substance, Drug product2020-10-28
N207999-002101740732033-06-17Drug substance2019-01-15
N207999-00292386732033-06-17Drug product2016-06-22
N207999-002100471172033-09-06U-18542018-11-14
N207999-002100523372036-04-26Drug product2018-11-08
N207999-002107513492036-04-26Drug product2020-08-28
N207999-002107585492036-04-26U-29452020-09-10

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-2784e616aacf4f…
2026-09-14 22:38:342026-08N207999-002OCALIVA10MGTABLET / ORALRLD2016-05-2784e616aacf4f…
2026-08-18 06:07:402026-07N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002OCALIVA10MGTABLET / ORALRLD2016-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-002OCALIVA10MGTABLET / ORALRLD2016-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207999-002OCALIVA10MGTABLET / ORALRLD2016-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207999-001OCALIVA5MGTABLET / ORALRLD2016-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207999-002OCALIVA10MGTABLET / ORALRLD, RS2016-05-2774a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207999-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207999-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207999-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207999-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207999-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207999-002AB13f0d92c62455…

Observed Orange Book patent history#

Patent history page 1 of 18 · 684 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N207999-001RE482862027-02-21Drug substance, Drug product2020-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N207999-001101740732033-06-17Drug substance2019-01-1584e616aacf4f…
2026-09-14 22:38:342026-08N207999-00192386732033-06-17Drug product2016-06-2284e616aacf4f…
2026-09-14 22:38:342026-08N207999-001100471172033-09-06U-18542018-11-1484e616aacf4f…
2026-09-14 22:38:342026-08N207999-001100523372036-04-26Drug product2018-11-0884e616aacf4f…
2026-09-14 22:38:342026-08N207999-001107513492036-04-26Drug product2020-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N207999-001107585492036-04-26U-29452020-09-1084e616aacf4f…
2026-09-14 22:38:342026-08N207999-002RE482862027-02-21Drug substance, Drug product2020-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N207999-002101740732033-06-17Drug substance2019-01-1584e616aacf4f…
2026-09-14 22:38:342026-08N207999-00292386732033-06-17Drug product2016-06-2284e616aacf4f…
2026-09-14 22:38:342026-08N207999-002100471172033-09-06U-18542018-11-1484e616aacf4f…
2026-09-14 22:38:342026-08N207999-002100523372036-04-26Drug product2018-11-0884e616aacf4f…
2026-09-14 22:38:342026-08N207999-002107513492036-04-26Drug product2020-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N207999-002107585492036-04-26U-29452020-09-1084e616aacf4f…
2026-08-18 06:07:402026-07N207999-001RE482862027-02-21Drug substance, Drug product2020-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-001101740732033-06-17Drug substance2019-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-00192386732033-06-17Drug product2016-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-001100471172033-09-06U-18542018-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-001100523372036-04-26Drug product2018-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-001107513492036-04-26Drug product2020-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-001107585492036-04-26U-29452020-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002RE482862027-02-21Drug substance, Drug product2020-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002101740732033-06-17Drug substance2019-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-00292386732033-06-17Drug product2016-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002100471172033-09-06U-18542018-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002100523372036-04-26Drug product2018-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002107513492036-04-26Drug product2020-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N207999-002107585492036-04-26U-29452020-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207999-001RE482862027-02-21Drug substance, Drug product2020-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-001101740732033-06-17Drug substance2019-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-00192386732033-06-17Drug product2016-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-001100471172033-09-06U-18542018-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-001100523372036-04-26Drug product2018-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-001107513492036-04-26Drug product2020-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-001107585492036-04-26U-29452020-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-002RE482862027-02-21Drug substance, Drug product2020-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-002101740732033-06-17Drug substance2019-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-00292386732033-06-17Drug product2016-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-002100471172033-09-06U-18542018-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207999-002100523372036-04-26Drug product2018-11-08011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207999-001ODE-1192023-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207999-002ODE-1192023-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207999-001ODE-1192023-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207999-002ODE-1192023-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207999-001ODE-1192023-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207999-002ODE-1192023-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207999-001NCE2021-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207999-001ODE-1192023-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207999-002NCE2021-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207999-002ODE-1192023-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207999-001ODE-1192023-05-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207999-002ODE-1192023-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207999-001NCE2021-05-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N207999-001ODE-1192023-05-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N207999-002NCE2021-05-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N207999-002ODE-1192023-05-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207999-001NCE2021-05-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207999-001ODE-1192023-05-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207999-002NCE2021-05-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207999-002ODE-1192023-05-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N207999-001NCE2021-05-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N207999-001ODE-1192023-05-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N207999-002NCE2021-05-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N207999-002ODE-1192023-05-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207999-001NCE2021-05-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N207999-001ODE-1192023-05-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N207999-002NCE2021-05-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N207999-002ODE-1192023-05-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207999-001NCE2021-05-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N207999-001ODE-1192023-05-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N207999-002NCE2021-05-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N207999-002ODE-1192023-05-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207999-001NCE2021-05-273f01610625f2…
2019-12-14 00:12 UTC2019-12N207999-001ODE-1192023-05-273f01610625f2…
2019-12-14 00:12 UTC2019-12N207999-002NCE2021-05-273f01610625f2…
2019-12-14 00:12 UTC2019-12N207999-002ODE-1192023-05-273f01610625f2…
2019-09-15 20:21 UTC2019-09N207999-001NCE2021-05-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N207999-001ODE-1192023-05-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N207999-002NCE2021-05-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N207999-002ODE-1192023-05-27b00525d2431f…

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70275SUPPL2022-02-28
70271SUPPL2022-02-28
67660SUPPL2021-06-02
67659SUPPL2021-06-02
67622SUPPL2021-05-28
67617SUPPL2021-05-27
52293SUPPL2018-02-02
52239SUPPL2018-02-01
52238SUPPL2018-02-01
44969ORIG2016-07-08
43542ORIG2016-07-08
40609ORIG2016-05-31
32875ORIG2016-05-31