Application 214311
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUGAMMADEX | SUGAMMADEX | INJECTABLE;INJECTION | 200MG/2ML | No | No |
| 002 | SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214311-001 | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-06-23 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214311-002 | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-06-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214311-001 | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-06-23 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214311-002 | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION / INTRAVENOUS | AP | 2023-06-23 | a67488948f0b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214311-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214311-002 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214311-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214311-002 | AP | 1 | a67488948f0b… |
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 |
|---|---|---|---|---|---|---|
| Sugammadex | SUGAMMADEX | Sandoz Inc | 6cf43d88-d410-439e-a2e5-e31086f14fc2 | 2026-01-31 | Warnings, Adverse reactions | 214311 ANDA214311 |