Application 021818
- Type
- NDA
- Sponsor
- ROMARK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALINIA | NITAZOXANIDE | TABLET; ORAL | 500MG | No | No |
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 |
|---|---|---|---|---|---|---|
| Nitazoxanide | NITAZOXANIDE | e5 Pharma, LLC | 40a7cc30-76cd-49fe-965a-7823c4140d0f | 2026-06-18 | Adverse reactions | NITAZOXANIDE |
| Nitazoxanide | NITAZOXANIDE | Camber Pharmaceuticals, Inc. | 295011e1-f919-4e5a-b9e7-4c784f623a86 | 2025-12-30 | Adverse reactions | NITAZOXANIDE |
| Nitazoxanide | NITAZOXANIDE | Rising Pharma Holdings, Inc. | c0dc0656-3c46-43f9-adea-5285c522cef8 | 2025-10-09 | Adverse reactions | NITAZOXANIDE |
| Nitazoxanide | NITAZOXANIDE | ANI Pharmaceuticals, Inc. | cd3652fa-a183-4fb6-9a21-73fbeba6fc4b | 2025-03-05 | Adverse reactions | NITAZOXANIDE |