Application 208744
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIGECYCLINE | TIGECYCLINE | POWDER;INTRAVENOUS | 50MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208744-001 | TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER / INTRAVENOUS | 2018-01-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N208744-001 | TIGECYCLINE | 50MG/VIAL | POWDER / INTRAVENOUS | 2018-01-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N208744-001 | TIGECYCLINE | 50MG/VIAL | POWDER / INTRAVENOUS | 2018-01-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N208744-001 | TIGECYCLINE | 50MG/VIAL | POWDER / INTRAVENOUS | 2018-01-18 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208744-001 | TIGECYCLINE | 50MG/VIAL | POWDER / INTRAVENOUS | 2018-01-18 | 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 |
|---|---|---|---|---|---|---|
| Tigecycline | TIGECYCLINE | Meitheal Pharmaceuticals Inc. | 6e9a34af-8dee-4ba2-9157-2f5cb46958a9 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | Tigecycline TIGECYCLINE |
| Tigecycline | TIGECYCLINE | Apotex Corp | 230484a8-408c-dcc1-d0c4-d9dd9a46831b | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | Tigecycline TIGECYCLINE |
| Tygacil | TIGECYCLINE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 2ccdb48e-c14a-4eeb-348c-4920ccfd7465 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | TIGECYCLINE |
| Tygacil | TIGECYCLINE | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | fd826e47-1b77-4ffd-bb22-fda3379903b0 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | TIGECYCLINE |
| Tigecycline | TIGECYCLINE | Meitheal Pharmaceuticals Inc. | 4cbefeb0-7d63-4c49-9906-384acc53dd15 | 2025-09-02 | Boxed warning, Warnings, Adverse reactions | Tigecycline TIGECYCLINE |
| Tigecycline | TIGECYCLINE | Sandoz Inc | 50605463-2dc2-4b27-bc51-4d87bb9a8539 | 2025-08-24 | Boxed warning, Warnings, Adverse reactions | Tigecycline TIGECYCLINE |
| Tigecycline | TIGECYCLINE | Eugia US LLC | dd58e0c3-d8a8-4cf2-96f8-9dd08f309579 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | Tigecycline TIGECYCLINE |
| Tigecycline | TIGECYCLINE | Amneal Pharmaceuticals LLC | 8450bd15-2b06-4fc7-b302-9021312e3f0d | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | Tigecycline TIGECYCLINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.