Application 206056
- Type
- NDA
- Sponsor
- B BRAUN MEDICAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | POWDER;INTRAVENOUS | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | Yes | Yes |
| 002 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | POWDER;INTRAVENOUS | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | Yes | Yes |
| 003 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | POWDER;INTRAVENOUS | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N206056-001 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | |
| N206056-002 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | |
| N206056-003 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 |
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 | N206056-001 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206056-002 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206056-003 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206056-001 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206056-002 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206056-003 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206056-001 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206056-002 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N206056-003 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206056-001 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206056-002 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206056-003 | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2025-04-03 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Piperacillin and Tazobactam and Sodium Chloride | PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE | B. Braun Medical Inc. | a63ca653-27d4-45fe-a744-77e0efe45220 | 2026-05-08 | Warnings, Adverse reactions | 206056 NDA206056 |