Application 211651

Type: NDA
Sponsor: PFIZER INC

Application Products#

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

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
N211651-001	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16
N211651-002	TALZENNA	TALAZOPARIB TOSYLATE	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16
N211651-003	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20
N211651-004	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20
N211651-005	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20
N211651-006	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211651-001	10780088	2029-07-27	U-3651		2023-07-19
N211651-001	8012976	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-001	9820985	2029-07-27	U-2437		2018-11-14
N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27
N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14
N211651-002	8012976	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-002	8420650	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-002	9820985	2029-07-27	U-2437		2018-11-14
N211651-002	10189837	2031-10-20		Drug substance, Drug product	2019-02-27
N211651-002	8735392	2031-10-20		Drug substance, Drug product	2018-11-14
N211651-003	10780088	2029-07-27	U-3651		2023-07-19
N211651-003	8012976	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-003	8420650	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-003	9820985	2029-07-27	U-2437		2021-10-19
N211651-003	10189837	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-003	8735392	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-004	8012976	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-004	8420650	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-004	9820985	2029-07-27	U-2437		2021-10-19
N211651-004	10189837	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-004	8735392	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-005	10780088	2029-07-27	U-3651		2023-07-19
N211651-005	8012976	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-005	8420650	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-005	9820985	2029-07-27	U-2437		2023-07-19
N211651-005	10189837	2031-10-20		Drug substance, Drug product	2023-07-19
N211651-005	8735392	2031-10-20		Drug substance, Drug product	2023-07-19
N211651-006	10780088	2029-07-27	U-3651		2023-07-19
N211651-006	8012976	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-006	8420650	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-006	9820985	2029-07-27	U-2437		2023-07-19
N211651-006	10189837	2031-10-20		Drug substance, Drug product	2023-07-19
N211651-006	8735392	2031-10-20		Drug substance, Drug product	2023-07-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211651-001	I-920	2026-06-20
N211651-003	I-920	2026-06-20
N211651-005	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 5 · 188 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	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,020 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	N211651-001	10780088	2029-07-27	U-3651		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	9820985	2029-07-27	U-2437		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	9820985	2029-07-27	U-2437		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	10780088	2029-07-27	U-3651		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	8012976	2029-07-27		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	8420650	2029-07-27		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	9820985	2029-07-27	U-2437		2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	10189837	2031-10-20		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	8735392	2031-10-20		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	8012976	2029-07-27		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	8420650	2029-07-27		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	9820985	2029-07-27	U-2437		2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	10189837	2031-10-20		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	8735392	2031-10-20		Drug substance, Drug product	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	10780088	2029-07-27	U-3651		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	8012976	2029-07-27		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	8420650	2029-07-27		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	9820985	2029-07-27	U-2437		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	10189837	2031-10-20		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	8735392	2031-10-20		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	10780088	2029-07-27	U-3651		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	8012976	2029-07-27		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	8420650	2029-07-27		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	9820985	2029-07-27	U-2437		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	10189837	2031-10-20		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	8735392	2031-10-20		Drug substance, Drug product	2023-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	10780088	2029-07-27	U-3651		2023-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	9820985	2029-07-27	U-2437		2018-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	8012976	2029-10-19		Drug substance, Drug product	2018-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 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	N211651-001	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	I-920	2026-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-003	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-005	I-920	2026-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211651-001	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-003	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-005	I-920	2026-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-001	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-003	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-005	I-920	2026-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-001	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-003	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-005	I-920	2026-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-001	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-003	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-005	I-920	2026-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-001	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-003	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-005	I-920	2026-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-001	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-003	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-005	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-001	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-003	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-005	I-920	2026-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211651-001	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211651-003	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211651-005	I-920	2026-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-001	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-003	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-005	I-920	2026-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-001	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-003	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-005	I-920	2026-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211651-001	I-920	2026-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211651-003	I-920	2026-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211651-005	I-920	2026-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211651-001	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	U.S. Pharmaceuticals	13839d4f-6acf-4ffb-a128-79df59319273	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211651 application number: NDA211651 ndc (product): 63539-295
Talzenna	TALAZOPARIB	Pfizer Laboratories Div Pfizer Inc	f2423edd-6d24-495c-aec1-c2f457f08d9a	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211651 application number: NDA211651 ndc (product): 0069-1751 ndc (product): 0069-0296 ndc (product): 0069-1195 ndc (product): 0069-1501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1501	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1501	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1751	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1751	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
46014-0296	Talzenna	talazoparib	Excella GmbH & Co. KG	NDA	Current
46014-1195	Talzenna	talazoparib	Excella GmbH & Co. KG	NDA	Current
63539-295	Talzenna	talazoparib	U.S. Pharmaceuticals	NDA	Current
63539-295	Talzenna	talazoparib	U.S. Pharmaceuticals	NDA	Current
63539-295	Talzenna	talazoparib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82570	SUPPL	2025-06-13
82561	SUPPL	2025-06-13
77417	SUPPL	2024-02-07
77415	SUPPL	2024-02-07
74581	SUPPL	2023-06-21
74554	SUPPL	2023-06-20
68697	SUPPL	2021-09-21
68696	SUPPL	2021-09-21
68670	SUPPL	2021-09-21
68572	SUPPL	2021-09-10
68569	SUPPL	2021-09-10
67835	SUPPL	2021-06-17
65034	SUPPL	2020-10-27
64991	SUPPL	2020-10-23
62110	SUPPL	2020-03-10
62103	SUPPL	2020-03-10
60111	SUPPL	2019-09-25
60096	SUPPL	2019-09-25
56167	ORIG	2018-10-29
55960	ORIG	2018-10-16
55956	ORIG	2018-10-16