Home Applications 207999 Application 207999
Type NDA
Sponsor INTERCEPT PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OCALIVA OBETICHOLIC ACID TABLET;ORAL 5MG Yes No 002 OCALIVA OBETICHOLIC ACID TABLET;ORAL 10MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207999-001 OCALIVA OBETICHOLIC ACID 5MG TABLET / ORAL RLD 2016-05-27 N207999-002 OCALIVA OBETICHOLIC ACID 10MG TABLET / ORAL RLD 2016-05-27
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207999-001 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 N207999-001 10174073 2033-06-17 Drug substance 2019-01-15 N207999-001 9238673 2033-06-17 Drug product 2016-06-22 N207999-001 10047117 2033-09-06 U-1854 2018-11-14 N207999-001 10052337 2036-04-26 Drug product 2018-11-08 N207999-001 10751349 2036-04-26 Drug product 2020-08-28 N207999-001 10758549 2036-04-26 U-2945 2020-09-10 N207999-002 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 N207999-002 10174073 2033-06-17 Drug substance 2019-01-15 N207999-002 9238673 2033-06-17 Drug product 2016-06-22 N207999-002 10047117 2033-09-06 U-1854 2018-11-14 N207999-002 10052337 2036-04-26 Drug product 2018-11-08 N207999-002 10751349 2036-04-26 Drug product 2020-08-28 N207999-002 10758549 2036-04-26 U-2945 2020-09-10
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 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 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 OCALIVA 10MG TABLET / ORAL RLD 2016-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 OCALIVA 10MG TABLET / ORAL RLD 2016-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-002 OCALIVA 10MG TABLET / ORAL RLD 2016-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207999-002 OCALIVA 10MG TABLET / ORAL RLD 2016-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207999-001 OCALIVA 5MG TABLET / ORAL RLD 2016-05-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207999-002 OCALIVA 10MG TABLET / ORAL RLD, RS 2016-05-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207999-001 AB 1 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207999-002 AB 1 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207999-001 AB 1 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207999-002 AB 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207999-001 AB 1 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207999-002 AB 1 3f0d92c62455…
Observed Orange Book patent history# Patent history page 1 of 18 · 684 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 N207999-001 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-001 10174073 2033-06-17 Drug substance 2019-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-001 9238673 2033-06-17 Drug product 2016-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-001 10047117 2033-09-06 U-1854 2018-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-001 10052337 2036-04-26 Drug product 2018-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-001 10751349 2036-04-26 Drug product 2020-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-001 10758549 2036-04-26 U-2945 2020-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 10174073 2033-06-17 Drug substance 2019-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 9238673 2033-06-17 Drug product 2016-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 10047117 2033-09-06 U-1854 2018-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 10052337 2036-04-26 Drug product 2018-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 10751349 2036-04-26 Drug product 2020-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207999-002 10758549 2036-04-26 U-2945 2020-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207999-001 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-001 10174073 2033-06-17 Drug substance 2019-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-001 9238673 2033-06-17 Drug product 2016-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-001 10047117 2033-09-06 U-1854 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-001 10052337 2036-04-26 Drug product 2018-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-001 10751349 2036-04-26 Drug product 2020-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-001 10758549 2036-04-26 U-2945 2020-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 10174073 2033-06-17 Drug substance 2019-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 9238673 2033-06-17 Drug product 2016-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 10047117 2033-09-06 U-1854 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 10052337 2036-04-26 Drug product 2018-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 10751349 2036-04-26 Drug product 2020-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207999-002 10758549 2036-04-26 U-2945 2020-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207999-001 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-001 10174073 2033-06-17 Drug substance 2019-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-001 9238673 2033-06-17 Drug product 2016-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-001 10047117 2033-09-06 U-1854 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-001 10052337 2036-04-26 Drug product 2018-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-001 10751349 2036-04-26 Drug product 2020-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-001 10758549 2036-04-26 U-2945 2020-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-002 RE48286 2027-02-21 Drug substance, Drug product 2020-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-002 10174073 2033-06-17 Drug substance 2019-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-002 9238673 2033-06-17 Drug product 2016-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-002 10047117 2033-09-06 U-1854 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207999-002 10052337 2036-04-26 Drug product 2018-11-08 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
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 NDC Name Nonproprietary name Labeler Marketing category Status 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-005 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current 69516-010 Ocaliva Obeticholic Acid Intercept Pharmaceuticals Inc NDA Current