Application 217439

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.1MG BASE	Yes	No
002	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.25MG BASE	Yes	No
003	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.35MG BASE	Yes	No
004	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.5MG BASE	Yes	No
005	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.75MG BASE	Yes	No
006	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 1MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N217439-001	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-002	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-003	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-004	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-005	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-006	TALZENNA	TALAZOPARIB TOSYLATE	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217439-001	10780088	2029-07-27	U-3651		2024-04-05
N217439-001	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-001	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-001	9820985	2029-07-27	U-2437		2024-04-05
N217439-001	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-001	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-002	10780088	2029-07-27	U-3651		2024-04-05
N217439-002	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-002	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-002	9820985	2029-07-27	U-2437		2024-04-05
N217439-002	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-002	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-003	10780088	2029-07-27	U-3651		2024-04-05
N217439-003	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-003	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-003	9820985	2029-07-27	U-2437		2024-04-05
N217439-003	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-003	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-004	10780088	2029-07-27	U-3651		2024-04-05
N217439-004	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-004	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-004	9820985	2029-07-27	U-2437		2024-04-05
N217439-004	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-004	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-005	10780088	2029-07-27	U-3651		2024-04-05
N217439-005	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-005	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-005	9820985	2029-07-27	U-2437		2024-04-05
N217439-005	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-005	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-006	10780088	2029-07-27	U-3651		2024-04-05
N217439-006	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-006	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-006	9820985	2029-07-27	U-2437		2024-04-05
N217439-006	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-006	8735392	2031-10-20		Drug substance, Drug product	2024-04-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217439-001	I-920	2026-06-20
N217439-002	I-920	2026-06-20
N217439-004	I-920	2026-06-20

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 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 540 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217439-001	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	10780088	2029-07-27	U-3651		2024-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	9820985	2029-07-27	U-2437		2024-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	8012976	2029-10-19		Drug substance, Drug product	2024-04-05	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217439-001	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	I-920	2026-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-002	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-004	I-920	2026-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217439-001	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-002	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-004	I-920	2026-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-001	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-002	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-004	I-920	2026-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-001	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-002	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-004	I-920	2026-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-001	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-002	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-004	I-920	2026-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-001	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-002	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-004	I-920	2026-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217439-001	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217439-002	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217439-004	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217439-001	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217439-002	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217439-004	I-920	2026-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217439-001	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217439-002	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217439-004	I-920	2026-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217439-001	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217439-002	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217439-004	I-920	2026-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217439-001	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217439-002	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217439-004	I-920	2026-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217439-001	I-920	2026-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217439-002	I-920	2026-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217439-004	I-920	2026-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217439-001	I-920	2026-06-20	`8072bd15b7f6…`

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
Talzenna	TALAZOPARIB	Pfizer Laboratories Div Pfizer Inc	c6fd147f-a77e-4a0b-9280-e82ecc41b4be	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217439 application number: NDA217439
Talzenna	TALAZOPARIB	U.S. Pharmaceuticals	b653221e-971f-4452-92d4-797924f1ff59	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217439 application number: NDA217439

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82571	SUPPL	2025-06-13
82562	SUPPL	2025-06-13
79802	ORIG	2024-10-03
77769	ORIG	2024-03-08
77762	ORIG	2024-03-08