Application 217150
- Type
- NDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/5ML (100MG/ML) | Yes | Yes |
| 002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | Yes | Yes |
| 003 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/20ML (100MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217150-001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-09-12 | |
| N217150-002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-09-12 | |
| N217150-003 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-09-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N217150-001 | CYCLOPHOSPHAMIDE | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-09-12 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N217150-002 | CYCLOPHOSPHAMIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-09-12 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N217150-003 | CYCLOPHOSPHAMIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-09-12 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Sandoz Inc | cf2f4b95-0327-499a-a5a3-51b1bdef68c5 | 2024-12-30 | Warnings, Adverse reactions | 217150 NDA217150 |