Application 019763
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IFEX | IFOSFAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | Yes | No |
| 002 | IFEX | IFOSFAMIDE | INJECTABLE;INJECTION | 3GM/VIAL | Yes | No |
| 003 | IFEX/MESNEX KIT | IFOSFAMIDE; MESNA | INJECTABLE;INJECTION | 1GM/VIAL;100MG/ML | No | No |
| 004 | IFEX/MESNEX KIT | IFOSFAMIDE; MESNA | INJECTABLE;INJECTION | 3GM/VIAL;100MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019763-001 | IFEX | IFOSFAMIDE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 |
| N019763-002 | IFEX | IFOSFAMIDE | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 |
| N019763-003 | IFEX/MESNEX KIT | IFOSFAMIDE; MESNA | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | ||
| N019763-004 | IFEX/MESNEX KIT | IFOSFAMIDE; MESNA | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019763-001 | AP |
| N019763-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019763-001 | IFEX | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019763-002 | IFEX | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | AP | RLD | 1988-12-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019763-003 | IFEX/MESNEX KIT | 1GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019763-004 | IFEX/MESNEX KIT | 3GM/VIAL;100MG/ML | INJECTABLE / INJECTION | 1992-10-10 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019763-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019763-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019763-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019763-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019763-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019763-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019763-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019763-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019763-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019763-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019763-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019763-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019763-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019763-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019763-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019763-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019763-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019763-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019763-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019763-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019763-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019763-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019763-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019763-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019763-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019763-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019763-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019763-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019763-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019763-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019763-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019763-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019763-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019763-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019763-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019763-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019763-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019763-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019763-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019763-002 | AP | 1 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| IFEX | IFOSFAMIDE | Baxter Healthcare Corporation | b7241707-7538-4d1a-91e7-3a25a91e0b9a | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 019763 NDA019763 0338-3991 0338-3993 |
| IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Company | 91e433a9-6800-43a6-ac13-a49a04a5aecd | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 019763 NDA019763 10019-926 10019-925 |
| IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Company | efb1d03b-2d91-406e-8110-d3a58b8fa7cc | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 019763 NDA019763 10019-927 10019-929 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-3991 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3991 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3991 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3991 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3993 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3993 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3993 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 0338-3993 | IFEX | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-925 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-925 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-925 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-925 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-926 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-926 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-926 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-926 | IFOSFAMIDE | IFOSFAMIDE | Baxter Healthcare Corporation | NDA | Current |
| 10019-927 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-927 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-927 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-927 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-929 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-929 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-929 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-929 | IFOSFAMIDE | ifosfamide | Baxter Healthcare Corporation | NDA | Current |