Cyclophosphamide Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Baxter Healthcare Corporation (2013-05-07)
- Oldest Current Product
- 1959-11-16
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\CYCLOPHOSPHAMIDE
- FDAOB
- INJECTION\INJECTION\CYCLOPHOSPHAMIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CYCLOPHOSPHAMIDE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CYCLOPHOSPHAMIDE - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CYCLOPHOSPHAMIDE ANHYDROUS
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CYCLOPHOSPHAMIDE ANHYDROUS
product(s) by strength(s)
cyclophosphamide 20 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 100190988 | NDA | Baxter Healthcare Corporation | 1959-11-16 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA012142 | 369e6911-66bd-4544-9901-cf887fdf1dc2 |
| 2 | 100190990 | NDA | Baxter Healthcare Corporation | 1959-11-16 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA012142 | 369e6911-66bd-4544-9901-cf887fdf1dc2 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 007813233 | ANDA | Sandoz Inc | 2014-10-31 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA204555 | 0e9e22fa-178a-42fc-9f82-c303db3b245a |
| 2 | 007813244 | ANDA | Sandoz Inc | 2014-10-31 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA204555 | 0e9e22fa-178a-42fc-9f82-c303db3b245a |
| 3 | 007813255 | ANDA | Sandoz Inc | 2014-10-31 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA204555 | 0e9e22fa-178a-42fc-9f82-c303db3b245a |
| 4 | 100190935 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe |
| 5 | 100190936 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe |
| 6 | 100190937 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe |
| 7 | 100190938 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 97ab446f-5017-4180-ae65-0a355289b0ed |
| 8 | 100190939 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 97ab446f-5017-4180-ae65-0a355289b0ed |
| 9 | 100190942 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 97ab446f-5017-4180-ae65-0a355289b0ed |
| 10 | 100190943 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | cef038cc-efab-46d9-99c2-95bb11d6c9bc |
| 11 | 100190944 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | cef038cc-efab-46d9-99c2-95bb11d6c9bc |
| 12 | 100190945 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | cef038cc-efab-46d9-99c2-95bb11d6c9bc |
| 13 | 100190955 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 591d9955-3d9c-4cdc-a308-2f1288376b9f |
| 14 | 100190956 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 591d9955-3d9c-4cdc-a308-2f1288376b9f |
| 15 | 100190957 | ANDA | Baxter Healthcare Corporation | 2008-05-21 | CYCLOPHOSPHAMIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA040745 | 591d9955-3d9c-4cdc-a308-2f1288376b9f |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040015 | NEOSAR | True | TEVA PARENTERAL MEDICINES INC | 1993-04-29 | ANDA040015_001, ANDA040015_002, ANDA040015_003, ANDA040015_004, ANDA040015_005 |
| 2 | ANDA040745 | CYCLOPHOSPHAMIDE | BAXTER HEALTHCARE CORP | 2008-05-21 | ANDA040745_001, ANDA040745_002, ANDA040745_003 | |
| 3 | ANDA087442 | NEOSAR | True | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 1982-02-16 | ANDA087442_001, ANDA087442_002, ANDA087442_003, ANDA087442_004, ANDA087442_005 |
| 4 | ANDA088371 | CYCLOPHOSPHAMIDE | True | BAXTER HEALTHCARE CORP | 1986-07-03 | ANDA088371_001 |
| 5 | ANDA088372 | CYCLOPHOSPHAMIDE | True | BAXTER HEALTHCARE CORP | 1986-07-03 | ANDA088372_001 |
| 6 | ANDA088373 | CYCLOPHOSPHAMIDE | True | BAXTER HEALTHCARE CORP | 1986-07-03 | ANDA088373_001 |
| 7 | ANDA088374 | CYCLOPHOSPHAMIDE | True | BAXTER HEALTHCARE CORP | 1986-09-24 | ANDA088374_001 |
| 8 | ANDA204555 | CYCLOPHOSPHAMIDE | JIANGSU HENGRUI MEDICINE CO LTD | 2014-10-31 | ANDA204555_001, ANDA204555_002, ANDA204555_003 | |
| 9 | NDA012142 | CYTOXAN | BAXTER HEALTHCARE CORP | NDA012142_001, NDA012142_002, NDA012142_003, NDA012142_004, NDA012142_005, NDA012142_006, NDA012142_007, NDA012142_008, NDA012142_009, NDA012142_010 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040015_001 | discontinued | CYCLOPHOSPHAMIDE (100MG/VIAL) | INJECTION | False | 1993-04-29 | NEOSAR | |
| 2 | ANDA040015_002 | discontinued | CYCLOPHOSPHAMIDE (200MG/VIAL) | INJECTION | False | 1993-04-29 | NEOSAR | |
| 3 | ANDA040015_003 | discontinued | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | False | 1993-04-29 | NEOSAR | |
| 4 | ANDA040015_004 | discontinued | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | False | 1993-04-29 | NEOSAR | |
| 5 | ANDA040015_005 | discontinued | CYCLOPHOSPHAMIDE (2GM/VIAL) | INJECTION | False | 1993-04-29 | NEOSAR | |
| 6 | ANDA040745_001 | RX | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | True | AP | 2008-05-21 | CYCLOPHOSPHAMIDE |
| 7 | ANDA040745_002 | RX | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | True | AP | 2008-05-21 | CYCLOPHOSPHAMIDE |
| 8 | ANDA040745_003 | RX | CYCLOPHOSPHAMIDE (2GM/VIAL) | INJECTION | True | AP | 2008-05-21 | CYCLOPHOSPHAMIDE |
| 9 | ANDA087442_001 | discontinued | CYCLOPHOSPHAMIDE (100MG/VIAL) | INJECTION | False | 1982-02-16 | NEOSAR | |
| 10 | ANDA087442_002 | discontinued | CYCLOPHOSPHAMIDE (200MG/VIAL) | INJECTION | False | 1982-02-16 | NEOSAR | |
| 11 | ANDA087442_003 | discontinued | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | False | 1982-02-16 | NEOSAR | |
| 12 | ANDA087442_004 | discontinued | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | False | 1983-07-08 | NEOSAR | |
| 13 | ANDA087442_005 | discontinued | CYCLOPHOSPHAMIDE (2GM/VIAL) | INJECTION | False | 1989-03-30 | NEOSAR | |
| 14 | ANDA088371_001 | discontinued | CYCLOPHOSPHAMIDE (100MG/VIAL) | INJECTION | False | 1986-07-03 | CYCLOPHOSPHAMIDE | |
| 15 | ANDA088372_001 | discontinued | CYCLOPHOSPHAMIDE (200MG/VIAL) | INJECTION | False | 1986-07-03 | CYCLOPHOSPHAMIDE | |
| 16 | ANDA088373_001 | discontinued | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | False | 1986-07-03 | CYCLOPHOSPHAMIDE | |
| 17 | ANDA088374_001 | discontinued | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | False | 1986-09-24 | CYCLOPHOSPHAMIDE | |
| 18 | ANDA204555_001 | RX | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | False | AP | 2014-10-31 | CYCLOPHOSPHAMIDE |
| 19 | ANDA204555_002 | RX | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | False | AP | 2014-10-31 | CYCLOPHOSPHAMIDE |
| 20 | ANDA204555_003 | RX | CYCLOPHOSPHAMIDE (2GM/VIAL) | INJECTION | False | AP | 2014-10-31 | CYCLOPHOSPHAMIDE |
| 21 | NDA012142_001 | discontinued | CYCLOPHOSPHAMIDE (100MG/VIAL) | INJECTION | False | CYTOXAN | ||
| 22 | NDA012142_002 | discontinued | CYCLOPHOSPHAMIDE (200MG/VIAL) | INJECTION | False | CYTOXAN | ||
| 23 | NDA012142_003 | RX | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | True | AP | CYTOXAN | |
| 24 | NDA012142_004 | RX | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | True | AP | 1982-08-30 | CYTOXAN |
| 25 | NDA012142_005 | RX | CYCLOPHOSPHAMIDE (2GM/VIAL) | INJECTION | True | AP | 1982-08-30 | CYTOXAN |
| 26 | NDA012142_006 | discontinued | CYCLOPHOSPHAMIDE (100MG/VIAL) | INJECTION | False | 1985-12-05 | CYTOXAN | |
| 27 | NDA012142_007 | discontinued | CYCLOPHOSPHAMIDE (200MG/VIAL) | INJECTION | False | 1985-12-10 | CYTOXAN | |
| 28 | NDA012142_008 | discontinued | CYCLOPHOSPHAMIDE (500MG/VIAL) | INJECTION | False | 1984-01-04 | CYTOXAN | |
| 29 | NDA012142_009 | discontinued | CYCLOPHOSPHAMIDE (2GM/VIAL) | INJECTION | False | 1985-12-10 | CYTOXAN | |
| 30 | NDA012142_010 | discontinued | CYCLOPHOSPHAMIDE (1GM/VIAL) | INJECTION | False | 1985-09-24 | CYTOXAN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0e9e22fa-178a-42fc-9f82-c303db3b245a (view SPL) | These highlights do not include all the information needed to useCYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959 | prescription | Human Prescription | Sandoz Inc | 2015-02-26 | 3 | 007813233, 007813244, 007813255 | |
| 2 | 369e6911-66bd-4544-9901-cf887fdf1dc2 (view SPL) | These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE injection, for intravenous use CYCLOPHOSPHAMIDE tablets, for oral useInitial U.S. Approval: 1959 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE | 2013-05-07 | 2 | 100190988, 100190990, 100190989 |
| 3 | 591d9955-3d9c-4cdc-a308-2f1288376b9f (view SPL) | These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous useInitial U.S. Approval: 1959 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-10-25 | 5 | 100190955, 100190956, 100190957 |
| 4 | 6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe (view SPL) | These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2015-01-31 | 2 | 100190935, 100190936, 100190937 |
| 5 | 97ab446f-5017-4180-ae65-0a355289b0ed (view SPL) | These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2015-01-31 | 2 | 100190938, 100190939, 100190942 |
| 6 | cef038cc-efab-46d9-99c2-95bb11d6c9bc (view SPL) | These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous useInitial U.S. Approval: 1959 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2015-01-31 | 2 | 100190943, 100190944, 100190945 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII