Home NDC 46014-0296 Talzenna
Product NDC 46014-0296
11-digit product format 460140296
Labeler code 46014
Product ID 46014-0296_84f244a3-ecbc-2887-e053-2991aa0acc2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name talazoparib
Dosage form CAPSULE
Route ORAL
Labeler Excella GmbH & Co. KG
Application NDA211651
Marketing category NDA
Marketing start 2018-10-26
Marketing end 0000-00-00
Substance TALAZOPARIB TOS
Active strength 0 mg/1
Pharmacologic classes Poly(ADP-Ribose
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 TE codes 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 · 194 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,054 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N211651-001 10780088 2029-07-27 U-3651 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-001 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-001 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-001 9820985 2029-07-27 U-2437 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-001 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-001 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-002 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-002 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-002 9820985 2029-07-27 U-2437 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-002 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-002 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 10780088 2029-07-27 U-3651 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 9820985 2029-07-27 U-2437 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-003 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-004 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-004 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-004 9820985 2029-07-27 U-2437 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-004 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-004 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 10780088 2029-07-27 U-3651 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 9820985 2029-07-27 U-2437 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-005 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 10780088 2029-07-27 U-3651 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 9820985 2029-07-27 U-2437 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211651-006 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 147 observed states.
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.