Application 214862

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OBETICHOLIC ACID	OBETICHOLIC ACID	TABLET;ORAL	5MG	No	No
002	OBETICHOLIC ACID	OBETICHOLIC ACID	TABLET; ORAL	10mg	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214862-001	OBETICHOLIC ACID	OBETICHOLIC ACID	5MG	TABLET / ORAL			2023-05-30
A214862-002	OBETICHOLIC ACID	OBETICHOLIC ACID	10MG	TABLET / ORAL			2023-05-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL		2023-05-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL		2023-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214862-001	OBETICHOLIC ACID	5MG	TABLET / ORAL	AB	2023-05-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214862-002	OBETICHOLIC ACID	10MG	TABLET / ORAL	AB	2023-05-30	`a67488948f0b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214862-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214862-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214862-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214862-002	AB	1	`3f0d92c62455…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74527	ORIG	2023-06-16