Application 012142
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYTOXAN | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CYTOXAN | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL | Yes | No |
| 004 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | Yes | No |
| 005 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | Yes | No |
| 006 | LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 008 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 009 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 010 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012142-001 | CYTOXAN | CYCLOPHOSPHAMIDE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012142-002 | CYTOXAN | CYCLOPHOSPHAMIDE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012142-003 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012142-004 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | |
| N012142-005 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | |
| N012142-006 | LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-05 | |
| N012142-007 | LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | |
| N012142-008 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-01-04 | |
| N012142-009 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | |
| N012142-010 | CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-09-24 |
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 | N012142-001 | CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012142-002 | CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012142-003 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012142-004 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012142-005 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012142-006 | LYOPHILIZED CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012142-007 | LYOPHILIZED CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012142-008 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012142-009 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012142-010 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-09-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-001 | CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012142-002 | CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012142-003 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012142-004 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-005 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-006 | LYOPHILIZED CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-007 | LYOPHILIZED CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-008 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-009 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012142-010 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-09-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-001 | CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012142-002 | CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012142-003 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012142-004 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-005 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-006 | LYOPHILIZED CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-007 | LYOPHILIZED CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-008 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-009 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012142-010 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-001 | CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-002 | CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-003 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-004 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-005 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-006 | LYOPHILIZED CYTOXAN | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-007 | LYOPHILIZED CYTOXAN | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-008 | CYTOXAN (LYOPHILIZED) | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-009 | CYTOXAN (LYOPHILIZED) | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-12-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012142-010 | CYTOXAN (LYOPHILIZED) | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-09-24 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | XGen Pharmaceuticals DJB, Inc. | 02e64046-687d-449e-e063-6294a90a6c32 | 2024-12-20 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Alembic Pharmaceuticals Limited | 9e699cf7-860e-4c03-9760-0c24d56df2de | 2024-12-16 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Alembic Pharmaceuticals Inc. | 3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea1 | 2024-12-10 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | NorthStar Rx LLC | 76f057be-e3da-0a89-e053-2a91aa0a8438 | 2024-11-20 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Hikma Pharmaceuticals USA Inc. | 8135b917-882f-4b4c-99b7-fa8ea54af4bf | 2024-11-19 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Fresenius Kabi USA, LLC | 31986d36-a1bf-4903-93a4-ce7386241ba1 | 2024-10-09 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Avyxa Pharma, LLC | 6f593585-e0dd-48bc-bd2b-c6c787e0b98c | 2024-07-26 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Baxter Healthcare Corporation | 769ded74-6186-40a8-8e44-ceff67287451 | 2020-08-07 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | Baxter Healthcare Company | cef038cc-efab-46d9-99c2-95bb11d6c9bc | 2017-03-15 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | Baxter Healthcare Company | 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe | 2017-03-15 | Warnings, Adverse reactions | CYCLOPHOSPHAMIDE |
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 |
|---|---|---|---|---|---|
| 10019-988 | CYCLOPHOSPHAMIDE | Cyclophosphamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-988 | CYCLOPHOSPHAMIDE | Cyclophosphamide | Baxter Healthcare Corpora | NDA | Current |
| 10019-989 | CYCLOPHOSPHAMIDE | Cyclophosphamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-989 | CYCLOPHOSPHAMIDE | Cyclophosphamide | Baxter Healthcare Corpora | NDA | Current |
| 10019-990 | CYCLOPHOSPHAMIDE | Cyclophosphamide | Baxter Healthcare Corporation | NDA | Current |
| 10019-990 | CYCLOPHOSPHAMIDE | Cyclophosphamide | Baxter Healthcare Corpora | NDA | Current |