Application 218142
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERIBULIN MESYLATE | ERIBULIN MESYLATE | SOLUTION;INTRAVENOUS | 1MG/2ML (0.5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218142-001 | ERIBULIN MESYLATE | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218142-001 | AP |
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 | A218142-001 | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218142-001 | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218142-001 | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-05 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218142-001 | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-05 | 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 | A218142-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218142-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218142-001 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218142-001 | AP | 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 |
|---|---|---|---|---|---|---|
| ERIBULIN MESYLATE | ERIBULIN MESYLATE | GLENMARK PHARMACEUTICALS INC., USA | 55f4017d-5ea8-4622-bf59-9b9c329097fd | 2025-10-03 | Warnings, Adverse reactions | 218142 ANDA218142 |
| ERIBULIN MESYLATE | ERIBULIN MESYLATE | Kindos Pharmaceuticals Co., Ltd. | 9bfd8ac7-57e2-4c9d-add8-26502cfb54a8 | 2025-08-07 | Warnings, Adverse reactions | 218142 ANDA218142 |