Application 219070

Type: NDA
Sponsor: CRINETICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PALSONIFY	PALTUSOTINE HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	No
002	PALSONIFY	PALTUSOTINE HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	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
N219070-001	PALSONIFY	PALTUSOTINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL		RLD	2025-09-25
N219070-002	PALSONIFY	PALTUSOTINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		RLD, RS	2025-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	10875839	2037-07-12	U-4283		2025-10-21
N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	10464918	2039-01-16		Drug substance	2025-10-21
N219070-001	11266641	2041-09-07	U-4283	Drug product	2025-10-21
N219070-001	11957674	2041-09-07	U-4283		2025-10-21
N219070-001	12208092	2044-03-25	U-4282		2025-10-21
N219070-002	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	10875839	2037-07-12	U-4283		2025-10-21
N219070-002	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	10464918	2039-01-16		Drug substance	2025-10-21
N219070-002	11266641	2041-09-07	U-4283	Drug product	2025-10-21
N219070-002	11957674	2041-09-07	U-4283		2025-10-21
N219070-002	12208092	2044-03-25	U-4282		2025-10-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219070-001	NCE	2030-09-25
N219070-001	ODE-537	2032-09-25
N219070-002	NCE	2030-09-25
N219070-002	ODE-537	2032-09-25

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
2026-09-14 22:38:34	2026-08	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 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	N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	10875839	2037-07-12	U-4283		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	10464918	2039-01-16		Drug substance	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	11957674	2041-09-07	U-4283		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	12208092	2044-03-25	U-4282		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	10875839	2037-07-12	U-4283		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	10464918	2039-01-16		Drug substance	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	11957674	2041-09-07	U-4283		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	12208092	2044-03-25	U-4282		2025-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	10875839	2037-07-12	U-4283		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	10464918	2039-01-16		Drug substance	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	11957674	2041-09-07	U-4283		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	12208092	2044-03-25	U-4282		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	10875839	2037-07-12	U-4283		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	10464918	2039-01-16		Drug substance	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	11957674	2041-09-07	U-4283		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	12208092	2044-03-25	U-4282		2025-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	10875839	2037-07-12	U-4283		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219070-001	NCE	2030-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-001	ODE-537	2032-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	NCE	2030-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219070-002	ODE-537	2032-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219070-001	NCE	2030-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-001	ODE-537	2032-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	NCE	2030-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219070-002	ODE-537	2032-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219070-001	NCE	2030-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	NCE	2030-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	NCE	2030-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	NCE	2030-09-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	NCE	2030-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	ODE-537	2032-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-002	NCE	2030-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-002	ODE-537	2032-09-25	`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
PALSONIFY	PALTUSOTINE	Crinetics Pharmaceuticals, Inc.	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219070 application number: NDA219070

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83898	ORIG	2025-10-23
83544	ORIG	2025-09-26
83530	ORIG	2025-09-26