Application 040745
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | Yes |
| 002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 1GM/VIAL | No | Yes |
| 003 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | INJECTABLE;INJECTION | 2GM/VIAL | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040745-001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 |
| A040745-002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 |
| A040745-003 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040745-001 | AP |
| A040745-002 | AP |
| A040745-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040745-002 | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040745-003 | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040745-001 | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2008-05-21 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040745-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040745-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040745-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040745-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040745-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040745-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040745-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040745-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040745-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040745-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040745-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040745-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040745-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040745-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040745-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040745-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040745-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040745-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040745-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040745-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040745-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040745-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040745-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040745-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040745-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040745-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040745-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040745-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040745-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040745-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040745-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040745-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040745-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040745-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040745-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040745-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040745-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040745-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040745-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040745-001 | AP | 1 | 1e350fbaab3a… |
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 | BluePoint Laboratories | d7e97b99-83db-42d0-8521-b87fe6467a67 | 2026-02-12 | Warnings, Adverse reactions | 040745 ANDA040745 68001-442 68001-444 68001-443 |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | Bamboo US Bidco LCC | 2873b99a-830d-0a7b-e063-6394a90a4de7 | 2025-12-03 | Warnings, Adverse reactions | 040745 ANDA040745 |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Civica, Inc. | 8627c83f-c057-495d-9f78-8b67bda97b3e | 2025-10-24 | Warnings, Adverse reactions | 040745 ANDA040745 72572-085 72572-087 72572-083 |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Baxter Healthcare Company | 591d9955-3d9c-4cdc-a308-2f1288376b9f | 2025-06-24 | Warnings, Adverse reactions | 040745 ANDA040745 10019-955 10019-957 10019-956 |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | Baxter Healthcare Company | 97ab446f-5017-4180-ae65-0a355289b0ed | 2025-06-20 | Warnings, Adverse reactions | 040745 ANDA040745 10019-938 10019-939 10019-942 |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | Baxter Healthcare Company | cef038cc-efab-46d9-99c2-95bb11d6c9bc | 2017-03-15 | Warnings, Adverse reactions | 040745 ANDA040745 10019-944 10019-945 10019-943 |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | Baxter Healthcare Company | 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe | 2017-03-15 | Warnings, Adverse reactions | 040745 ANDA040745 10019-937 10019-936 10019-935 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10019-935 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-935 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-935 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-935 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-936 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-936 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-936 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-936 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-937 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-937 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-937 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-937 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-938 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-938 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-938 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-938 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-939 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-939 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-939 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-939 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-942 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-942 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-942 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-942 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-943 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-943 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-943 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-943 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-944 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-944 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-944 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-944 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-945 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-945 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-945 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-945 | CYCLOPHOSPHAMIDE | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-955 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-955 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-955 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-955 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-956 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-956 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-956 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-956 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-957 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-957 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-957 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 10019-957 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare Corporation | ANDA | Current |
| 68001-442 | Cyclophosphamide | cyclophosphamide | BluePoint Laboratories | ANDA | Current |
| 68001-443 | Cyclophosphamide | cyclophosphamide | BluePoint Laboratories | ANDA | Current |
| 68001-444 | Cyclophosphamide | cyclophosphamide | BluePoint Laboratories | ANDA | Current |
| 72572-083 | Cyclophosphamide | cyclophosphamide | Civica, Inc. | ANDA | Current |
| 72572-085 | Cyclophosphamide | cyclophosphamide | Civica, Inc. | ANDA | Current |
| 72572-087 | Cyclophosphamide | cyclophosphamide | Civica, Inc. | ANDA | Current |