Application 219488

Type: NDA
Sponsor: MIRUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CTEXLI	CHENODIOL	TABLET;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219488-001	CTEXLI	CHENODIOL	250MG	TABLET / ORAL		RLD, RS	2025-02-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219488-001	NP	2028-02-21
N219488-001	ODE-523	2032-02-21

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.

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	N219488-001	CTEXLI	250MG	TABLET / ORAL	RLD, RS	2025-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219488-001	CTEXLI	250MG	TABLET / ORAL	RLD, RS	2025-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219488-001	CTEXLI	250MG	TABLET / ORAL	RLD, RS	2025-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219488-001	CTEXLI	250MG	TABLET / ORAL	RLD, RS	2025-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219488-001	CTEXLI	250MG	TABLET / ORAL	RLD, RS	2025-02-21	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219488-001	CTEXLI	250MG	TABLET / ORAL	RLD, RS	2025-02-21	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N219488-001	NP	2028-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219488-001	ODE-523	2032-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219488-001	NP	2028-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219488-001	NP	2028-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219488-001	NP	2028-02-21	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219488-001	NP	2028-02-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219488-001	ODE-523	2032-02-21	`a50c72e98297…`

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
CTEXLI	CHENODIOL	Mirum Pharmaceuticals Inc.	015384e7-4ac5-4782-a309-e40cd1421c5b	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219488 application number: NDA219488

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84907	ORIG	2026-02-04
81310	ORIG	2025-02-21
81309	ORIG	2025-02-21