Application 210661
- Type
- NDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 100MG | No | No |
| 002 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210661-001 | AXTLE | PEMETREXED DIPOTASSIUM | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | |
| N210661-002 | AXTLE | PEMETREXED DIPOTASSIUM | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210661-001 | PEMETREXED | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210661-002 | PEMETREXED | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210661-001 | PEMETREXED | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210661-002 | PEMETREXED | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210661-001 | PEMETREXED | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210661-002 | PEMETREXED | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210661-001 | PEMETREXED | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210661-002 | PEMETREXED | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210661-001 | PEMETREXED | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210661-002 | PEMETREXED | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210661-001 | PEMETREXED | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210661-002 | PEMETREXED | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 301d65b070ca… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210661-001 | AXTLE | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210661-002 | AXTLE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2024-06-28 | 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 |
|---|---|---|---|---|---|---|
| AXTLE | PEMETREXED | Avyxa Pharma, LLC | 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1 | 2025-10-08 | Warnings, Adverse reactions | 210661 NDA210661 |
| PEMETREXED DIPOTASSIUM | PEMETREXED DIPOTASSIUM | Avyxa Pharma, LLC | adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc | 2025-02-05 | Warnings, Adverse reactions | 210661 NDA210661 |