Application 219083

Type: NDA
Sponsor: CYTOKINETICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYQORZO	AFICAMTEN	TABLET;ORAL	5MG	Yes	Yes
002	MYQORZO	AFICAMTEN	TABLET;ORAL	10MG	Yes	No
003	MYQORZO	AFICAMTEN	TABLET;ORAL	15MG	Yes	No
004	MYQORZO	AFICAMTEN	TABLET;ORAL	20MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219083-001	MYQORZO	AFICAMTEN	5MG	TABLET / ORAL	RLD, RS	2025-12-19
N219083-002	MYQORZO	AFICAMTEN	10MG	TABLET / ORAL	RLD	2025-12-19
N219083-003	MYQORZO	AFICAMTEN	15MG	TABLET / ORAL	RLD	2025-12-19
N219083-004	MYQORZO	AFICAMTEN	20MG	TABLET / ORAL	RLD	2025-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-001	12370179	2042-07-15	U-4371		2026-01-13
N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-002	12370179	2042-07-15	U-4371		2026-01-13
N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-003	12370179	2042-07-15	U-4371		2026-01-13
N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-004	12370179	2042-07-15	U-4371		2026-01-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219083-001	NCE	2030-12-19
N219083-002	NCE	2030-12-19
N219083-003	NCE	2030-12-19
N219083-004	NCE	2030-12-19

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
2026-10-15 13:18:30	2026-09	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N219083-001	NCE	2030-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	NCE	2030-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	NCE	2030-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	NCE	2030-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219083-001	NCE	2030-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	NCE	2030-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	NCE	2030-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	NCE	2030-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219083-001	NCE	2030-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	NCE	2030-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	NCE	2030-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	NCE	2030-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219083-001	NCE	2030-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	NCE	2030-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	NCE	2030-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	NCE	2030-12-19	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	NCE	2030-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	NCE	2030-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	NCE	2030-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	NCE	2030-12-19	`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
MYQORZO	AFICAMTEN	Cytokinetics Inc.	fd778507-1274-4d1a-a659-5431d55c543a	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219083 application number: NDA219083

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
84959	SUPPL	2026-02-06
84774	ORIG	2026-01-16
84515	ORIG	2025-12-23
84480	ORIG	2025-12-22