Application 217512
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | SOLUTION;INTRAVENOUS | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | Yes | Yes |
| 002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | SOLUTION;INTRAVENOUS | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | Yes | Yes |
| 003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | SOLUTION;INTRAVENOUS | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217512-001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | |
| N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | |
| N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N217512-001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N217512-001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N217512-001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N217512-001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 6a51e52b5d6a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217512-001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217512-002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217512-003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-02-14 | 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 |
|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | Baxter Healthcare Company | a476e063-9450-4793-9a22-16b0a0a61cd0 | 2024-02-14 | Warnings, Adverse reactions | 217512 NDA217512 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.