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)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1100190988NDABaxter Healthcare Corporation1959-11-16CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA012142369e6911-66bd-4544-9901-cf887fdf1dc2
2100190990NDABaxter Healthcare Corporation1959-11-16CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA012142369e6911-66bd-4544-9901-cf887fdf1dc2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813233ANDASandoz Inc2014-10-31CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA2045550e9e22fa-178a-42fc-9f82-c303db3b245a
2007813244ANDASandoz Inc2014-10-31CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA2045550e9e22fa-178a-42fc-9f82-c303db3b245a
3007813255ANDASandoz Inc2014-10-31CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA2045550e9e22fa-178a-42fc-9f82-c303db3b245a
4100190935ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0407456bae5c14-9e87-4fb6-ae9c-4d875c1ecffe
5100190936ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0407456bae5c14-9e87-4fb6-ae9c-4d875c1ecffe
6100190937ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0407456bae5c14-9e87-4fb6-ae9c-4d875c1ecffe
7100190938ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA04074597ab446f-5017-4180-ae65-0a355289b0ed
8100190939ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA04074597ab446f-5017-4180-ae65-0a355289b0ed
9100190942ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA04074597ab446f-5017-4180-ae65-0a355289b0ed
10100190943ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA040745cef038cc-efab-46d9-99c2-95bb11d6c9bc
11100190944ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA040745cef038cc-efab-46d9-99c2-95bb11d6c9bc
12100190945ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA040745cef038cc-efab-46d9-99c2-95bb11d6c9bc
13100190955ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA040745591d9955-3d9c-4cdc-a308-2f1288376b9f
14100190956ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA040745591d9955-3d9c-4cdc-a308-2f1288376b9f
15100190957ANDABaxter Healthcare Corporation2008-05-21CYCLOPHOSPHAMIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA040745591d9955-3d9c-4cdc-a308-2f1288376b9f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040015NEOSARTrueTEVA PARENTERAL MEDICINES INC1993-04-29ANDA040015_001, ANDA040015_002, ANDA040015_003, ANDA040015_004, ANDA040015_005
2ANDA040745CYCLOPHOSPHAMIDEBAXTER HEALTHCARE CORP2008-05-21ANDA040745_001, ANDA040745_002, ANDA040745_003
3ANDA087442NEOSARTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1982-02-16ANDA087442_001, ANDA087442_002, ANDA087442_003, ANDA087442_004, ANDA087442_005
4ANDA088371CYCLOPHOSPHAMIDETrueBAXTER HEALTHCARE CORP1986-07-03ANDA088371_001
5ANDA088372CYCLOPHOSPHAMIDETrueBAXTER HEALTHCARE CORP1986-07-03ANDA088372_001
6ANDA088373CYCLOPHOSPHAMIDETrueBAXTER HEALTHCARE CORP1986-07-03ANDA088373_001
7ANDA088374CYCLOPHOSPHAMIDETrueBAXTER HEALTHCARE CORP1986-09-24ANDA088374_001
8ANDA204555CYCLOPHOSPHAMIDEJIANGSU HENGRUI MEDICINE CO LTD2014-10-31ANDA204555_001, ANDA204555_002, ANDA204555_003
9NDA012142CYTOXANBAXTER HEALTHCARE CORPNDA012142_001, NDA012142_002, NDA012142_003, NDA012142_004, NDA012142_005, NDA012142_006, NDA012142_007, NDA012142_008, NDA012142_009, NDA012142_010

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040015_001discontinuedCYCLOPHOSPHAMIDE (100MG/VIAL)INJECTIONFalse1993-04-29NEOSAR
2ANDA040015_002discontinuedCYCLOPHOSPHAMIDE (200MG/VIAL)INJECTIONFalse1993-04-29NEOSAR
3ANDA040015_003discontinuedCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONFalse1993-04-29NEOSAR
4ANDA040015_004discontinuedCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONFalse1993-04-29NEOSAR
5ANDA040015_005discontinuedCYCLOPHOSPHAMIDE (2GM/VIAL)INJECTIONFalse1993-04-29NEOSAR
6ANDA040745_001RXCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONTrueAP2008-05-21CYCLOPHOSPHAMIDE
7ANDA040745_002RXCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONTrueAP2008-05-21CYCLOPHOSPHAMIDE
8ANDA040745_003RXCYCLOPHOSPHAMIDE (2GM/VIAL)INJECTIONTrueAP2008-05-21CYCLOPHOSPHAMIDE
9ANDA087442_001discontinuedCYCLOPHOSPHAMIDE (100MG/VIAL)INJECTIONFalse1982-02-16NEOSAR
10ANDA087442_002discontinuedCYCLOPHOSPHAMIDE (200MG/VIAL)INJECTIONFalse1982-02-16NEOSAR
11ANDA087442_003discontinuedCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONFalse1982-02-16NEOSAR
12ANDA087442_004discontinuedCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONFalse1983-07-08NEOSAR
13ANDA087442_005discontinuedCYCLOPHOSPHAMIDE (2GM/VIAL)INJECTIONFalse1989-03-30NEOSAR
14ANDA088371_001discontinuedCYCLOPHOSPHAMIDE (100MG/VIAL)INJECTIONFalse1986-07-03CYCLOPHOSPHAMIDE
15ANDA088372_001discontinuedCYCLOPHOSPHAMIDE (200MG/VIAL)INJECTIONFalse1986-07-03CYCLOPHOSPHAMIDE
16ANDA088373_001discontinuedCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONFalse1986-07-03CYCLOPHOSPHAMIDE
17ANDA088374_001discontinuedCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONFalse1986-09-24CYCLOPHOSPHAMIDE
18ANDA204555_001RXCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONFalseAP2014-10-31CYCLOPHOSPHAMIDE
19ANDA204555_002RXCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONFalseAP2014-10-31CYCLOPHOSPHAMIDE
20ANDA204555_003RXCYCLOPHOSPHAMIDE (2GM/VIAL)INJECTIONFalseAP2014-10-31CYCLOPHOSPHAMIDE
21NDA012142_001discontinuedCYCLOPHOSPHAMIDE (100MG/VIAL)INJECTIONFalseCYTOXAN
22NDA012142_002discontinuedCYCLOPHOSPHAMIDE (200MG/VIAL)INJECTIONFalseCYTOXAN
23NDA012142_003RXCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONTrueAPCYTOXAN
24NDA012142_004RXCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONTrueAP1982-08-30CYTOXAN
25NDA012142_005RXCYCLOPHOSPHAMIDE (2GM/VIAL)INJECTIONTrueAP1982-08-30CYTOXAN
26NDA012142_006discontinuedCYCLOPHOSPHAMIDE (100MG/VIAL)INJECTIONFalse1985-12-05CYTOXAN
27NDA012142_007discontinuedCYCLOPHOSPHAMIDE (200MG/VIAL)INJECTIONFalse1985-12-10CYTOXAN
28NDA012142_008discontinuedCYCLOPHOSPHAMIDE (500MG/VIAL)INJECTIONFalse1984-01-04CYTOXAN
29NDA012142_009discontinuedCYCLOPHOSPHAMIDE (2GM/VIAL)INJECTIONFalse1985-12-10CYTOXAN
30NDA012142_010discontinuedCYCLOPHOSPHAMIDE (1GM/VIAL)INJECTIONFalse1985-09-24CYTOXAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10e9e22fa-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: 1959prescriptionHuman PrescriptionSandoz Inc2015-02-263007813233, 007813244, 007813255
2369e6911-66bd-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: 1959prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2013-05-072100190988, 100190990, 100190989
3591d9955-3d9c-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: 1959prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-10-255100190955, 100190956, 100190957
46bae5c14-9e87-4fb6-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: 1959prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-312100190935, 100190936, 100190937
597ab446f-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: 1959prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-312100190938, 100190939, 100190942
6cef038cc-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: 1959prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-312100190943, 100190944, 100190945

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII