Application 050684
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | Yes | Yes |
| 002 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | Yes | Yes |
| 003 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | Yes | Yes |
| 004 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050684-001 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | |
| N050684-002 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | |
| N050684-003 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | |
| N050684-004 | ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050684-001 | ZOSYN | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050684-002 | ZOSYN | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050684-003 | ZOSYN | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050684-004 | ZOSYN | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-10-22 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N050684-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-003 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-004 | AP | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N050684-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N050684-002 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N050684-003 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N050684-004 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050684-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N050684-002 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N050684-003 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N050684-004 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050684-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050684-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050684-003 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050684-004 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050684-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050684-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050684-003 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050684-004 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050684-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050684-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050684-003 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050684-004 | AP | 1 | ea99ee380514… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-001 | 6900184 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-001 | 7915229 | 2023-04-14 | Drug product | 2011-04-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-001 | 8133883 | 2023-04-14 | U-282 | Drug product | 2012-04-11 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-002 | 6900184 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-002 | 7915229 | 2023-04-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-002 | 8133883 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-003 | 6900184 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-003 | 7915229 | 2023-04-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-003 | 8133883 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-004 | 6900184 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-004 | 7915229 | 2023-04-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050684-004 | 8133883 | 2023-04-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-001 | 6900184 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-001 | 7915229 | 2023-04-14 | Drug product | 2011-04-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-001 | 8133883 | 2023-04-14 | U-282 | Drug product | 2012-04-11 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-002 | 6900184 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-002 | 7915229 | 2023-04-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050684-002 | 8133883 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-003 | 6900184 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-003 | 7915229 | 2023-04-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050684-003 | 8133883 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-004 | 6900184 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050684-004 | 7915229 | 2023-04-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050684-004 | 8133883 | 2023-04-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-001 | 6900184 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-001 | 7915229 | 2023-04-14 | Drug product | 2011-04-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-001 | 8133883 | 2023-04-14 | U-282 | Drug product | 2012-04-11 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-002 | 6900184 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-002 | 7915229 | 2023-04-14 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050684-002 | 8133883 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-003 | 6900184 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-003 | 7915229 | 2023-04-14 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050684-003 | 8133883 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-004 | 6900184 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050684-004 | 7915229 | 2023-04-14 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050684-004 | 8133883 | 2023-04-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-001 | 6900184 | 2023-04-14 | U-282 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-001 | 7915229 | 2023-04-14 | Drug product | 2011-04-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-001 | 8133883 | 2023-04-14 | U-282 | Drug product | 2012-04-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050684-002 | 6900184 | 2023-04-14 | U-282 | Drug product | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Zosyn | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM | Baxter Healthcare Corporation | 8db6bd91-2106-4bfd-8cc8-38aaf1e18d17 | 2026-05-15 | Warnings, Adverse reactions | Zosyn |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0206-8852 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8852 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8852 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8854 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8854 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8854 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8855 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8855 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8855 | Zosyn | piperacillin sodium and tazobactam sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8859 | Zosyn | PIPERACILLIN SODIUM and TAZOBACTAM SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8859 | Zosyn | PIPERACILLIN SODIUM and TAZOBACTAM SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0206-8859 | Zosyn | PIPERACILLIN SODIUM and TAZOBACTAM SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80515 | SUPPL | 2024-12-05 |
| 80492 | SUPPL | 2024-12-04 |
| 78385 | SUPPL | 2024-05-03 |
| 78352 | SUPPL | 2024-05-02 |
| 72932 | SUPPL | 2022-12-20 |
| 72921 | SUPPL | 2022-12-19 |
| 70749 | SUPPL | 2022-04-11 |
| 70742 | SUPPL | 2022-04-11 |
| 68264 | SUPPL | 2021-08-02 |
| 68238 | SUPPL | 2021-08-02 |
| 63326 | SUPPL | 2020-05-28 |
| 63302 | SUPPL | 2020-05-27 |
| 62564 | SUPPL | 2020-04-14 |
| 62556 | SUPPL | 2020-04-14 |
| 58700 | SUPPL | 2019-05-14 |
| 58676 | SUPPL | 2019-05-14 |
| 48309 | SUPPL | 2017-05-09 |
| 48308 | SUPPL | 2017-05-09 |
| 48307 | SUPPL | 2017-05-09 |
| 48272 | SUPPL | 2017-05-08 |
| 48271 | SUPPL | 2017-05-08 |
| 48270 | SUPPL | 2017-05-08 |
| 39111 | SUPPL | 2016-06-13 |
| 39110 | SUPPL | 2016-06-13 |
| 30274 | SUPPL | 2016-06-13 |
| 8002 | SUPPL | 2016-06-13 |
| 18018 | SUPPL | 2015-12-29 |
| 8001 | SUPPL | 2015-12-22 |
| 30273 | SUPPL | 2013-09-11 |
| 30272 | SUPPL | 2013-09-11 |
| 8000 | SUPPL | 2013-09-11 |
| 39109 | SUPPL | 2013-09-09 |
| 18017 | SUPPL | 2013-09-09 |
| 18016 | SUPPL | 2013-09-09 |
| 30271 | SUPPL | 2012-05-15 |
| 18015 | SUPPL | 2012-05-15 |
| 18014 | SUPPL | 2012-05-15 |
| 7999 | SUPPL | 2011-10-03 |
| 39108 | SUPPL | 2011-09-30 |
| 39107 | SUPPL | 2008-06-05 |
| 18013 | SUPPL | 2008-06-05 |
| 30270 | SUPPL | 2008-04-22 |
| 7998 | SUPPL | 2008-04-22 |
| 22183 | SUPPL | 2007-06-11 |
| 7997 | SUPPL | 2006-08-04 |
| 18012 | SUPPL | 2006-07-27 |
| 30269 | SUPPL | 2005-10-20 |
| 18011 | SUPPL | 2005-10-10 |
| 7996 | SUPPL | 2005-06-29 |
| 7995 | SUPPL | 2005-03-18 |
| 30268 | SUPPL | 2004-02-03 |
| 7994 | SUPPL | 2003-05-30 |
| 7993 | SUPPL | 2003-05-29 |
| 39106 | SUPPL | 2003-05-06 |
| 39105 | SUPPL | 2003-04-30 |
| 7992 | SUPPL | 2002-03-27 |