Application 216099

Type: NDA
Sponsor: HANDA THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHYRAGO	DASATINIB	TABLET;ORAL	20MG	Yes	No
002	PHYRAGO	DASATINIB	TABLET;ORAL	50MG	Yes	No
003	PHYRAGO	DASATINIB	TABLET;ORAL	70MG	Yes	No
004	PHYRAGO	DASATINIB	TABLET;ORAL	80MG	Yes	No
005	PHYRAGO	DASATINIB	TABLET;ORAL	100MG	Yes	Yes
006	PHYRAGO	DASATINIB	TABLET;ORAL	140MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216099-001	PHYRAGO	DASATINIB	20MG	TABLET / ORAL	RLD	2023-12-05
N216099-002	PHYRAGO	DASATINIB	50MG	TABLET / ORAL	RLD	2023-12-05
N216099-003	PHYRAGO	DASATINIB	70MG	TABLET / ORAL	RLD	2023-12-05
N216099-004	PHYRAGO	DASATINIB	80MG	TABLET / ORAL	RLD	2023-12-05
N216099-005	PHYRAGO	DASATINIB	100MG	TABLET / ORAL	RLD, RS	2023-12-05
N216099-006	PHYRAGO	DASATINIB	140MG	TABLET / ORAL	RLD	2023-12-05

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216099-001	11202778	2041-01-22	U-3770		2023-12-22
N216099-001	11202778	2041-01-22	U-3771		2023-12-22
N216099-001	11202778	2041-01-22	U-3772		2023-12-22
N216099-001	11298356	2041-01-22		Drug product	2023-12-22
N216099-001	11324745	2041-01-22	U-3767		2023-12-22
N216099-001	11324745	2041-01-22	U-3768		2023-12-22
N216099-001	11324745	2041-01-22	U-3769		2023-12-22
N216099-001	12433891	2041-01-22	U-3767		2025-10-21
N216099-001	12433891	2041-01-22	U-3768		2025-10-21
N216099-001	12433891	2041-01-22	U-3769		2025-10-21
N216099-001	12433891	2041-01-22	U-3770		2025-10-21
N216099-001	12433891	2041-01-22	U-3771		2025-10-21
N216099-001	12433891	2041-01-22	U-3772		2025-10-21
N216099-001	12465606	2041-01-22		Drug product	2025-11-14
N216099-001	12544376	2041-01-22	U-3767		2026-02-17
N216099-001	12544376	2041-01-22	U-3768		2026-02-17
N216099-001	12544376	2041-01-22	U-3769		2026-02-17
N216099-001	12544376	2041-01-22	U-3770		2026-02-17
N216099-001	12544376	2041-01-22	U-3771		2026-02-17
N216099-001	12544376	2041-01-22	U-3772		2026-02-17
N216099-002	11202778	2041-01-22	U-3770		2023-12-22
N216099-002	11202778	2041-01-22	U-3771		2023-12-22
N216099-002	11202778	2041-01-22	U-3772		2023-12-22
N216099-002	11298356	2041-01-22		Drug product	2023-12-22
N216099-002	11324745	2041-01-22	U-3767		2023-12-22
N216099-002	11324745	2041-01-22	U-3768		2023-12-22
N216099-002	11324745	2041-01-22	U-3769		2023-12-22
N216099-002	12433891	2041-01-22	U-3767		2025-10-21
N216099-002	12433891	2041-01-22	U-3768		2025-10-21
N216099-002	12433891	2041-01-22	U-3769		2025-10-21
N216099-002	12433891	2041-01-22	U-3770		2025-10-21
N216099-002	12433891	2041-01-22	U-3771		2025-10-21
N216099-002	12433891	2041-01-22	U-3772		2025-10-21
N216099-002	12465606	2041-01-22		Drug product	2025-11-14
N216099-002	12544376	2041-01-22	U-3767		2026-02-17
N216099-002	12544376	2041-01-22	U-3768		2026-02-17
N216099-002	12544376	2041-01-22	U-3769		2026-02-17
N216099-002	12544376	2041-01-22	U-3770		2026-02-17
N216099-002	12544376	2041-01-22	U-3771		2026-02-17
N216099-002	12544376	2041-01-22	U-3772		2026-02-17
N216099-003	11202778	2041-01-22	U-3770		2023-12-22
N216099-003	11202778	2041-01-22	U-3771		2023-12-22
N216099-003	11202778	2041-01-22	U-3772		2023-12-22
N216099-003	11298356	2041-01-22		Drug product	2023-12-22
N216099-003	11324745	2041-01-22	U-3767		2023-12-22
N216099-003	11324745	2041-01-22	U-3768		2023-12-22
N216099-003	11324745	2041-01-22	U-3769		2023-12-22
N216099-003	12433891	2041-01-22	U-3767		2025-10-21
N216099-003	12433891	2041-01-22	U-3768		2025-10-21
N216099-003	12433891	2041-01-22	U-3769		2025-10-21
N216099-003	12433891	2041-01-22	U-3770		2025-10-21
N216099-003	12433891	2041-01-22	U-3771		2025-10-21
N216099-003	12433891	2041-01-22	U-3772		2025-10-21
N216099-003	12465606	2041-01-22		Drug product	2025-11-14
N216099-003	12544376	2041-01-22	U-3767		2026-02-17
N216099-003	12544376	2041-01-22	U-3768		2026-02-17
N216099-003	12544376	2041-01-22	U-3769		2026-02-17
N216099-003	12544376	2041-01-22	U-3770		2026-02-17
N216099-003	12544376	2041-01-22	U-3771		2026-02-17
N216099-003	12544376	2041-01-22	U-3772		2026-02-17
N216099-004	11202778	2041-01-22	U-3770		2023-12-22
N216099-004	11202778	2041-01-22	U-3771		2023-12-22
N216099-004	11202778	2041-01-22	U-3772		2023-12-22
N216099-004	11298356	2041-01-22		Drug product	2023-12-22
N216099-004	11324745	2041-01-22	U-3767		2023-12-22
N216099-004	11324745	2041-01-22	U-3768		2023-12-22
N216099-004	11324745	2041-01-22	U-3769		2023-12-22
N216099-004	12433891	2041-01-22	U-3767		2025-10-21
N216099-004	12433891	2041-01-22	U-3768		2025-10-21
N216099-004	12433891	2041-01-22	U-3769		2025-10-21
N216099-004	12433891	2041-01-22	U-3770		2025-10-21
N216099-004	12433891	2041-01-22	U-3771		2025-10-21
N216099-004	12433891	2041-01-22	U-3772		2025-10-21
N216099-004	12465606	2041-01-22		Drug product	2025-11-14
N216099-004	12544376	2041-01-22	U-3767		2026-02-17
N216099-004	12544376	2041-01-22	U-3768		2026-02-17
N216099-004	12544376	2041-01-22	U-3769		2026-02-17
N216099-004	12544376	2041-01-22	U-3770		2026-02-17
N216099-004	12544376	2041-01-22	U-3771		2026-02-17
N216099-004	12544376	2041-01-22	U-3772		2026-02-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216099-001	M-307	2026-12-05
N216099-002	M-307	2026-12-05
N216099-003	M-307	2026-12-05
N216099-004	M-307	2026-12-05
N216099-005	M-307	2026-12-05
N216099-006	M-307	2026-12-05

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 · 114 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	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-005	PHYRAGO	100MG	TABLET / ORAL	RLD, RS	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-006	PHYRAGO	140MG	TABLET / ORAL	RLD	2023-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216099-005	PHYRAGO	100MG	TABLET / ORAL	RLD, RS	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216099-006	PHYRAGO	140MG	TABLET / ORAL	RLD	2023-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216099-005	PHYRAGO	100MG	TABLET / ORAL	RLD, RS	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216099-006	PHYRAGO	140MG	TABLET / ORAL	RLD	2023-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216099-005	PHYRAGO	100MG	TABLET / ORAL	RLD, RS	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216099-006	PHYRAGO	140MG	TABLET / ORAL	RLD	2023-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216099-005	PHYRAGO	100MG	TABLET / ORAL	RLD, RS	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216099-006	PHYRAGO	140MG	TABLET / ORAL	RLD	2023-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216099-005	PHYRAGO	100MG	TABLET / ORAL	RLD, RS	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216099-006	PHYRAGO	140MG	TABLET / ORAL	RLD	2023-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216099-001	PHYRAGO	20MG	TABLET / ORAL	RLD	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216099-002	PHYRAGO	50MG	TABLET / ORAL	RLD	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216099-003	PHYRAGO	70MG	TABLET / ORAL	RLD	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216099-004	PHYRAGO	80MG	TABLET / ORAL	RLD	2023-12-05	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,116 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	N216099-001	11202778	2041-01-22	U-3770		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	11202778	2041-01-22	U-3771		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	11202778	2041-01-22	U-3772		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	11298356	2041-01-22		Drug product	2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	11324745	2041-01-22	U-3767		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	11324745	2041-01-22	U-3768		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	11324745	2041-01-22	U-3769		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12433891	2041-01-22	U-3769		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12433891	2041-01-22	U-3768		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12433891	2041-01-22	U-3767		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12433891	2041-01-22	U-3770		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12433891	2041-01-22	U-3771		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12433891	2041-01-22	U-3772		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12465606	2041-01-22		Drug product	2025-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12544376	2041-01-22	U-3767		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12544376	2041-01-22	U-3768		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12544376	2041-01-22	U-3769		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12544376	2041-01-22	U-3770		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12544376	2041-01-22	U-3771		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-001	12544376	2041-01-22	U-3772		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11202778	2041-01-22	U-3770		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11202778	2041-01-22	U-3771		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11202778	2041-01-22	U-3772		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11298356	2041-01-22		Drug product	2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11324745	2041-01-22	U-3768		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11324745	2041-01-22	U-3769		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	11324745	2041-01-22	U-3767		2023-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12433891	2041-01-22	U-3768		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12433891	2041-01-22	U-3767		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12433891	2041-01-22	U-3769		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12433891	2041-01-22	U-3770		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12433891	2041-01-22	U-3771		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12433891	2041-01-22	U-3772		2025-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12465606	2041-01-22		Drug product	2025-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12544376	2041-01-22	U-3767		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12544376	2041-01-22	U-3768		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12544376	2041-01-22	U-3769		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12544376	2041-01-22	U-3770		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12544376	2041-01-22	U-3771		2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216099-002	12544376	2041-01-22	U-3772		2026-02-17	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216099-005	M-307	2026-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216099-006	M-307	2026-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216099-001	M-307	2026-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216099-002	M-307	2026-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216099-003	M-307	2026-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216099-004	M-307	2026-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216099-005	M-307	2026-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216099-006	M-307	2026-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216099-001	M-307	2026-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216099-002	M-307	2026-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216099-003	M-307	2026-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216099-004	M-307	2026-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216099-005	M-307	2026-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216099-006	M-307	2026-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216099-001	M-307	2026-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216099-002	M-307	2026-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216099-003	M-307	2026-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216099-004	M-307	2026-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216099-005	M-307	2026-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216099-006	M-307	2026-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216099-001	M-307	2026-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216099-002	M-307	2026-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216099-003	M-307	2026-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216099-004	M-307	2026-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216099-005	M-307	2026-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216099-006	M-307	2026-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216099-001	M-307	2026-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216099-002	M-307	2026-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216099-003	M-307	2026-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216099-004	M-307	2026-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216099-005	M-307	2026-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216099-006	M-307	2026-12-05	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216099-001	M-307	2026-12-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216099-002	M-307	2026-12-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216099-003	M-307	2026-12-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216099-004	M-307	2026-12-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216099-005	M-307	2026-12-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216099-006	M-307	2026-12-05	`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
PHYRAGO	DASATINIB	Cycle Pharmaceuticals Ltd	60976d1e-c415-417f-8168-4e07999a7281	2025-08-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216099 application number: NDA216099

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
83050	SUPPL	2025-08-05
83038	SUPPL	2025-08-04
80524	SUPPL	2024-12-05
80502	SUPPL	2024-12-04
79744	ORIG	2024-09-26
79283	SUPPL	2024-08-02
79275	SUPPL	2024-08-02
76742	ORIG	2023-12-06
74316	ORIG	2023-12-06