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
Orange Book products#
| 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#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N211651-001 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | |
| 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 | |
| N211651-001 | 8012976 | 2032-10-16 | 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 | |
| N211651-002 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2018-11-14 | |
| N211651-003 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | |
| 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 | |
| N211651-003 | 8012976 | 2032-10-16 | 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 | |
| N211651-004 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2021-10-19 | |
| N211651-005 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N211651-005 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2023-07-19 | |
| N211651-006 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N211651-006 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2023-07-19 |
Orange Book exclusivity#
| 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | TALZENNA | EQ 0.25MG BASE | CAPSULE / ORAL | RLD | 2018-10-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-002 | TALZENNA | EQ 1MG BASE | CAPSULE / ORAL | RLD | 2018-10-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | TALZENNA | EQ 0.5MG BASE | CAPSULE / ORAL | RLD | 2021-09-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-004 | TALZENNA | EQ 0.75MG BASE | CAPSULE / ORAL | RLD | 2021-09-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | TALZENNA | EQ 0.1MG BASE | CAPSULE / ORAL | RLD | 2023-06-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | TALZENNA | EQ 0.35MG BASE | CAPSULE / ORAL | RLD | 2023-06-20 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | TALZENNA | EQ 0.25MG BASE | CAPSULE / ORAL | RLD | 2018-10-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-002 | TALZENNA | EQ 1MG BASE | CAPSULE / ORAL | RLD | 2018-10-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-003 | TALZENNA | EQ 0.5MG BASE | CAPSULE / ORAL | RLD | 2021-09-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-004 | TALZENNA | EQ 0.75MG BASE | CAPSULE / ORAL | RLD | 2021-09-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-005 | TALZENNA | EQ 0.1MG BASE | CAPSULE / ORAL | RLD | 2023-06-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-006 | TALZENNA | EQ 0.35MG BASE | CAPSULE / ORAL | RLD | 2023-06-20 | 84e616aacf4f… | |
| 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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | 9820985 | 2029-07-27 | U-2437 | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2019-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-001 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-002 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-002 | 9820985 | 2029-07-27 | U-2437 | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-002 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2019-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-002 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-002 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2018-11-14 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | 9820985 | 2029-07-27 | U-2437 | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-003 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-004 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-004 | 9820985 | 2029-07-27 | U-2437 | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-004 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-004 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-004 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2021-10-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | 9820985 | 2029-07-27 | U-2437 | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-005 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | 9820985 | 2029-07-27 | U-2437 | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N211651-006 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2023-07-19 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | 10780088 | 2029-07-27 | U-3651 | 2023-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | 8012976 | 2029-07-27 | Drug substance, Drug product | 2018-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2018-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | 9820985 | 2029-07-27 | U-2437 | 2018-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2019-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211651-001 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2018-11-14 | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N211651-003 | NCE | 2023-10-16 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N211651-004 | NCE | 2023-10-16 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211651-001 | NCE | 2023-10-16 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211651-002 | NCE | 2023-10-16 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211651-003 | NCE | 2023-10-16 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211651-004 | NCE | 2023-10-16 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N211651-001 | NCE | 2023-10-16 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N211651-002 | NCE | 2023-10-16 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N211651-003 | NCE | 2023-10-16 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N211651-004 | NCE | 2023-10-16 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N211651-001 | NCE | 2023-10-16 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N211651-002 | NCE | 2023-10-16 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N211651-003 | NCE | 2023-10-16 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N211651-004 | NCE | 2023-10-16 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N211651-001 | NCE | 2023-10-16 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N211651-002 | NCE | 2023-10-16 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N211651-003 | NCE | 2023-10-16 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N211651-004 | NCE | 2023-10-16 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N211651-001 | NCE | 2023-10-16 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N211651-002 | NCE | 2023-10-16 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N211651-003 | NCE | 2023-10-16 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N211651-004 | NCE | 2023-10-16 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N211651-001 | NCE | 2023-10-16 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N211651-002 | NCE | 2023-10-16 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N211651-003 | NCE | 2023-10-16 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N211651-004 | NCE | 2023-10-16 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N211651-001 | NCE | 2023-10-16 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N211651-002 | NCE | 2023-10-16 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N211651-003 | NCE | 2023-10-16 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N211651-004 | NCE | 2023-10-16 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211651-001 | I-920 | 2026-06-20 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211651-003 | I-920 | 2026-06-20 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211651-005 | I-920 | 2026-06-20 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
| 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 | 211651 NDA211651 |
| Talzenna | TALAZOPARIB | Pfizer Laboratories Div Pfizer Inc | f2423edd-6d24-495c-aec1-c2f457f08d9a | 2025-12-18 | Warnings, Adverse reactions | 211651 NDA211651 |