Home Applications 050684 Application 050684
Type NDA
Sponsor WYETH PHARMS Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table 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SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1993-10-22 N050684-002 ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1993-10-22 N050684-003 ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1993-10-22 N050684-004 ZOSYN PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1993-10-22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.
Product history page 3 of 5 · 176 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 2019-12-13 00:20 UTC 2019-12 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION RLD 1993-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050684-001 ZOSYN EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050684-002 ZOSYN EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050684-003 ZOSYN EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050684-004 ZOSYN EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-10-22 ea99ee380514…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 288 observed states.
Captured, Edition, Application-product table 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table 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 Name fallback brand name: Zosyn
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table 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