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 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 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.
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 2026-08-01 22:54:32 2026-06 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N211651-001 10780088 2029-07-27 U-3651 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-001 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-001 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-001 9820985 2029-07-27 U-2437 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-001 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-001 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-002 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-002 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-002 9820985 2029-07-27 U-2437 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-002 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-002 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 10780088 2029-07-27 U-3651 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 9820985 2029-07-27 U-2437 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-004 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-004 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-004 9820985 2029-07-27 U-2437 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-004 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-004 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 10780088 2029-07-27 U-3651 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 9820985 2029-07-27 U-2437 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 10780088 2029-07-27 U-3651 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 9820985 2029-07-27 U-2437 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-006 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N211651-001 I-920 2026-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-003 I-920 2026-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211651-005 I-920 2026-06-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.