Application 205750

Type: NDA
Sponsor: RTRX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHOLBAM	CHOLIC ACID	CAPSULE;ORAL	50MG	Yes	No
002	CHOLBAM	CHOLIC ACID	CAPSULE;ORAL	250MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N205750-001	CHOLBAM	CHOLIC ACID	50MG	CAPSULE / ORAL		RLD	2015-03-17
N205750-002	CHOLBAM	CHOLIC ACID	250MG	CAPSULE / ORAL		RLD, RS	2015-03-17

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-001	ODE-91	2022-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-002	ODE-91	2022-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205750-001	ODE-91	2022-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205750-002	ODE-91	2022-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205750-001	ODE-91	2022-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205750-002	ODE-91	2022-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205750-001	NCE	2020-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-001	ODE-91	2022-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-002	NCE	2020-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-002	ODE-91	2022-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205750-001	ODE-91	2022-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205750-002	ODE-91	2022-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205750-001	ODE-91	2022-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205750-002	ODE-91	2022-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205750-001	ODE-91	2022-03-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205750-002	ODE-91	2022-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205750-001	ODE-91	2022-03-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205750-002	ODE-91	2022-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205750-001	NCE	2020-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205750-001	ODE-91	2022-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205750-002	NCE	2020-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205750-002	ODE-91	2022-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205750-001	NCE	2020-03-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205750-001	ODE-91	2022-03-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205750-002	NCE	2020-03-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205750-002	ODE-91	2022-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205750-001	NCE	2020-03-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205750-001	ODE-91	2022-03-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205750-002	NCE	2020-03-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205750-002	ODE-91	2022-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205750-001	NCE	2020-03-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205750-001	ODE-91	2022-03-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205750-002	NCE	2020-03-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205750-002	ODE-91	2022-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205750-001	NCE	2020-03-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205750-001	ODE-91	2022-03-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205750-002	NCE	2020-03-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205750-002	ODE-91	2022-03-17	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N205750-001	ODE-91	2022-03-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205750-002	ODE-91	2022-03-17	`3bdfa0b2c4d7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHOLBAM	CHOLIC ACID	Mirum Pharmaceuticals Inc.	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205750 application number: NDA205750

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45043-001	Cholbam	Cholic Acid	Manchester Pharmaceuticals, LLC	NDA	Current
45043-001	Cholbam	Cholic Acid	Retrophin, Inc	NDA	Current
45043-001	Cholbam	Cholic Acid	Manchester Pharmaceuticals	NDA	Current
45043-001	Cholbam	Cholic Acid	Retrophin, Inc	NDA	Current
45043-001	Cholbam	Cholic Acid	Manchester Pharmaceuticals, LLC	NDA	Current
45043-001	Cholbam	Cholic Acid	Manchester Pharmaceuticals, LLC	NDA	Current
45043-002	Cholbam	Cholic Acid	Manchester Pharmaceuticals, LLC	NDA	Current
45043-002	Cholbam	Cholic Acid	Retrophin, Inc	NDA	Current
45043-002	Cholbam	Cholic Acid	Manchester Pharmaceuticals	NDA	Current
45043-002	Cholbam	Cholic Acid	Retrophin, Inc	NDA	Current
45043-002	Cholbam	Cholic Acid	Manchester Pharmaceuticals, LLC	NDA	Current
45043-002	Cholbam	Cholic Acid	Manchester Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85993	SUPPL	2026-05-21
85988	SUPPL	2026-05-21
65035	SUPPL	2020-10-27
64993	SUPPL	2020-10-23
43501	ORIG	2015-04-13
32714	ORIG	2015-03-18
19679	ORIG	2015-03-18