Application 214844
- Type
- ANDA
- Sponsor
- ANI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITAZOXANIDE | NITAZOXANIDE | TABLET;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214844-001 | NITAZOXANIDE | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214844-001 | AB |
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 | A214844-001 | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214844-001 | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214844-001 | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214844-001 | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214844-001 | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214844-001 | NITAZOXANIDE | 500MG | TABLET / ORAL | AB | 2025-02-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A214844-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214844-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214844-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214844-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214844-001 | AB | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214844-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Nitazoxanide | NITAZOXANIDE | e5 Pharma, LLC | 40a7cc30-76cd-49fe-965a-7823c4140d0f | 2026-06-18 | Adverse reactions | 214844 ANDA214844 |
| Nitazoxanide | NITAZOXANIDE | ANI Pharmaceuticals, Inc. | cd3652fa-a183-4fb6-9a21-73fbeba6fc4b | 2025-03-05 | Adverse reactions | 214844 ANDA214844 |