Application 217439
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217439-001 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N217439-001 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2024-04-05 | |
| N217439-002 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N217439-002 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2024-04-05 | |
| N217439-003 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N217439-003 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2024-04-05 | |
| N217439-004 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N217439-004 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2024-04-05 | |
| N217439-005 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N217439-005 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2024-04-05 | |
| N217439-006 | 10780088 | 2029-07-27 | U-3651 | 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 | |
| N217439-006 | 8012976 | 2032-10-16 | Drug substance, Drug product | 2024-04-05 |
Orange Book exclusivity#
| 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.
| 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 | N217439-001 | TALZENNA | EQ 0.1MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217439-002 | TALZENNA | EQ 0.25MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217439-003 | TALZENNA | EQ 0.35MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217439-004 | TALZENNA | EQ 0.5MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217439-005 | TALZENNA | EQ 0.75MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217439-006 | TALZENNA | EQ 1MG BASE | CAPSULE / ORAL | RLD, RS | 2024-03-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N217439-001 | TALZENNA | EQ 0.1MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217439-002 | TALZENNA | EQ 0.25MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217439-003 | TALZENNA | EQ 0.35MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217439-004 | TALZENNA | EQ 0.5MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217439-005 | TALZENNA | EQ 0.75MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217439-006 | TALZENNA | EQ 1MG BASE | CAPSULE / ORAL | RLD, RS | 2024-03-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217439-001 | TALZENNA | EQ 0.1MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217439-002 | TALZENNA | EQ 0.25MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217439-003 | TALZENNA | EQ 0.35MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217439-004 | TALZENNA | EQ 0.5MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217439-005 | TALZENNA | EQ 0.75MG BASE | CAPSULE / ORAL | RLD | 2024-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217439-006 | TALZENNA | EQ 1MG BASE | CAPSULE / ORAL | RLD, RS | 2024-03-07 | caaa826d4ba7… | |
| 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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-003 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-003 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-004 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-004 | 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 | N217439-004 | 9820985 | 2029-07-27 | U-2437 | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-004 | 8012976 | 2029-10-19 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-004 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-004 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-005 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-005 | 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 | N217439-005 | 9820985 | 2029-07-27 | U-2437 | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-005 | 8012976 | 2029-10-19 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-005 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-005 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-006 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-006 | 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 | N217439-006 | 9820985 | 2029-07-27 | U-2437 | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-006 | 8012976 | 2029-10-19 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-006 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217439-006 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-001 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-001 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-001 | 9820985 | 2029-07-27 | U-2437 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-001 | 8012976 | 2029-10-19 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-001 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-001 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-002 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-002 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-002 | 9820985 | 2029-07-27 | U-2437 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-002 | 8012976 | 2029-10-19 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-002 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-002 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-003 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-003 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-003 | 9820985 | 2029-07-27 | U-2437 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-003 | 8012976 | 2029-10-19 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-003 | 10189837 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-003 | 8735392 | 2031-10-20 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-004 | 10780088 | 2029-07-27 | U-3651 | 2024-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217439-004 | 8420650 | 2029-07-27 | Drug substance, Drug product | 2024-04-05 | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N217439-001 | I-920 | 2026-06-20 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N217439-002 | I-920 | 2026-06-20 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N217439-004 | I-920 | 2026-06-20 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N217439-001 | I-920 | 2026-06-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N217439-002 | I-920 | 2026-06-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N217439-004 | I-920 | 2026-06-20 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N217439-001 | I-920 | 2026-06-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N217439-002 | I-920 | 2026-06-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N217439-004 | I-920 | 2026-06-20 | caaa826d4ba7… |
| 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… |
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 | Pfizer Laboratories Div Pfizer Inc | c6fd147f-a77e-4a0b-9280-e82ecc41b4be | 2026-04-10 | Warnings, Adverse reactions | 217439 NDA217439 |
| Talzenna | TALAZOPARIB | U.S. Pharmaceuticals | b653221e-971f-4452-92d4-797924f1ff59 | 2024-07-09 | Warnings, Adverse reactions | 217439 NDA217439 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.