Application 216196

Type: NDA
Sponsor: AGIOS PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRUKYND	MITAPIVAT	TABLET;ORAL	5MG	No	No
002	PYRUKYND	MITAPIVAT	TABLET;ORAL	20MG	No	No
003	PYRUKYND	MITAPIVAT	TABLET;ORAL	50MG	No	No
004	AQVESME	MITAPIVAT SULFATE	TABLET;ORAL	EQ 100MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216196-001	PYRUKYND	MITAPIVAT SULFATE	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17
N216196-002	PYRUKYND	MITAPIVAT SULFATE	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17
N216196-003	PYRUKYND	MITAPIVAT SULFATE	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17
N216196-004	AQVESME	MITAPIVAT SULFATE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216196-001	10632114	2032-05-03	U-3320		2022-03-08
N216196-001	9682080	2032-05-03	U-3319		2022-03-08
N216196-001	9980961	2032-05-03	U-3319		2022-03-08
N216196-001	9193701	2032-10-26	U-3319		2022-03-08
N216196-001	11793806	2033-04-12	U-3320		2023-10-31
N216196-001	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27
N216196-001	11234976	2038-10-11	U-3321		2022-03-08
N216196-001	11254652	2038-11-21		Drug substance, Drug product	2022-03-08
N216196-001	11878049	2041-07-31	U-3782		2024-01-26
N216196-002	10632114	2032-05-03	U-3320		2022-03-08
N216196-002	9682080	2032-05-03	U-3319		2022-03-08
N216196-002	9980961	2032-05-03	U-3319		2022-03-08
N216196-002	9193701	2032-10-26	U-3319		2022-03-08
N216196-002	11793806	2033-04-12	U-3320		2023-10-31
N216196-002	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27
N216196-002	11234976	2038-10-11	U-3321		2022-03-08
N216196-002	11254652	2038-11-21		Drug substance, Drug product	2022-03-08
N216196-002	11878049	2041-07-31	U-3782		2024-01-26
N216196-003	10632114	2032-05-03	U-3320		2022-03-08
N216196-003	9682080	2032-05-03	U-3319		2022-03-08
N216196-003	9980961	2032-05-03	U-3319		2022-03-08
N216196-003	9193701	2032-10-26	U-3319		2022-03-08
N216196-003	11793806	2033-04-12	U-3320		2023-10-31
N216196-003	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27
N216196-003	11234976	2038-10-11	U-3321		2022-03-08
N216196-003	11254652	2038-11-21		Drug substance, Drug product	2022-03-08
N216196-003	11878049	2041-07-31	U-3782		2024-01-26
N216196-004	10632114	2032-05-03	U-4391		2026-01-20
N216196-004	9682080	2032-05-03	U-4392		2026-01-20
N216196-004	9193701	2032-10-26	U-4393		2026-01-20
N216196-004	RE49582	2035-04-11		Drug substance, Drug product	2026-01-20
N216196-004	11254652	2038-11-21		Drug substance, Drug product	2026-01-20
N216196-004	11878049	2041-07-31	U-4390		2026-01-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 9 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216196-001	NCE	2027-02-17
N216196-001	ODE-392	2029-02-17
N216196-002	NCE	2027-02-17
N216196-002	ODE-392	2029-02-17
N216196-003	NCE	2027-02-17
N216196-003	ODE-392	2029-02-17
N216196-004	NCE	2027-02-17
N216196-004	NP	2028-12-23
N216196-004	ODE-522	2032-12-23

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 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	AQVESME	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	AQVESME	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-004	AQVESME	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 837 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	N216196-001	10632114	2032-05-03	U-3320		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	9682080	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	9980961	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	9193701	2032-10-26	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11793806	2033-04-12	U-3320		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11234976	2038-10-11	U-3321		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11254652	2038-11-21		Drug substance, Drug product	2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11878049	2041-07-31	U-3782		2024-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	10632114	2032-05-03	U-3320		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	9682080	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	9980961	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	9193701	2032-10-26	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11793806	2033-04-12	U-3320		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11234976	2038-10-11	U-3321		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11254652	2038-11-21		Drug substance, Drug product	2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11878049	2041-07-31	U-3782		2024-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	10632114	2032-05-03	U-3320		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	9682080	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	9980961	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	9193701	2032-10-26	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11793806	2033-04-12	U-3320		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11234976	2038-10-11	U-3321		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11254652	2038-11-21		Drug substance, Drug product	2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11878049	2041-07-31	U-3782		2024-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	10632114	2032-05-03	U-4391		2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	9682080	2032-05-03	U-4392		2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	9193701	2032-10-26	U-4393		2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	RE49582	2035-04-11		Drug substance, Drug product	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	11254652	2038-11-21		Drug substance, Drug product	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	11878049	2041-07-31	U-4390		2026-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216196-001	10632114	2032-05-03	U-3320		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	9682080	2032-05-03	U-3319		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	9980961	2032-05-03	U-3319		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	9193701	2032-10-26	U-3319		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	11793806	2033-04-12	U-3320		2023-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	11234976	2038-10-11	U-3321		2022-03-08	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N216196-001	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	ODE-392	2029-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	ODE-392	2029-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	ODE-392	2029-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	NP	2028-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	ODE-522	2032-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216196-001	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	ODE-392	2029-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-002	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-002	ODE-392	2029-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-003	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-003	ODE-392	2029-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	NP	2028-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	ODE-522	2032-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216196-001	NCE	2027-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-001	ODE-392	2029-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-002	NCE	2027-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-002	ODE-392	2029-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-003	NCE	2027-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-003	ODE-392	2029-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-001	NCE	2027-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-001	ODE-392	2029-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-002	NCE	2027-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-002	ODE-392	2029-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-003	NCE	2027-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-003	ODE-392	2029-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216196-001	NCE	2027-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-001	ODE-392	2029-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-002	NCE	2027-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-002	ODE-392	2029-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-003	NCE	2027-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-003	ODE-392	2029-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-001	NCE	2027-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-001	ODE-392	2029-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-002	NCE	2027-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-002	ODE-392	2029-02-17	`fd3edfee7708…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AQVESME	MITAPIVAT	Agios Pharmaceuticals, Inc.	1d4e2654-1636-0d01-e063-6394a90af303	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216196 application number: NDA216196
PYRUKYND	MITAPIVAT	Agios Pharmaceuticals, Inc.	4ccee896-e313-4c6c-9674-b4746ada0a90	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216196 application number: NDA216196 ndc (product): 71334-210 ndc (product): 71334-230 ndc (product): 71334-215 ndc (product): 71334-205 ndc (product): 71334-220 ndc (product): 71334-225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71334-205	Pyrukynd	mitapivat	Agios Pharmaceuticals, Inc.	NDA	Current
71334-210	Pyrukynd	mitapivat	Agios Pharmaceuticals, Inc.	NDA	Current
71334-215	Pyrukynd	mitapivat	Agios Pharmaceuticals, Inc.	NDA	Current
71334-220	Pyrukynd	mitapivat	Agios Pharmaceuticals, Inc.	NDA	Current
71334-225	Pyrukynd	mitapivat	Agios Pharmaceuticals, Inc.	NDA	Current
71334-230	Pyrukynd	mitapivat	Agios Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84839	SUPPL	2026-01-27
84628	SUPPL	2026-01-02
84592	SUPPL	2025-12-29
80819	SUPPL	2025-01-07
80817	SUPPL	2025-01-06
70547	ORIG	2022-03-17
70194	ORIG	2022-02-18
70184	ORIG	2022-02-17