Cyclosporine Injectable Solution

Brand(s)
Sandimmune
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-03-31)
Oldest Current Product
1983-11-14
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CYCLOSPORINE
FDAOB
INJECTION\INJECTION\CYCLOSPORINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\CYCLOSPORINE
INTRAVENOUS\INJECTION\CYCLOSPORINE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\CYCLOSPORINE
INTRAVENOUS\INJECTION\CYCLOSPORINE

product(s) by strength(s)

cyclosporine 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780109SandimmuneNDANovartis Pharmaceuticals Corporation1983-11-14CYCLOSPORINEINTRAVENOUSINJECTIONNDA0505735e5926a7-1de0-4b54-a5c0-286b6200ff82

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740866ANDAPaddock Laboratories, Llc2003-10-07CYCLOSPORINEINTRAVENOUSINJECTION, SOLUTIONANDA0651515977b562-3624-427c-bc64-b07247751b9e

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA065004CYCLOSPORINEEUROHEALTH INTERNATIONAL SARL1999-10-29ANDA065004_001
2ANDA065151CYCLOSPORINELUITPOLD PHARMACEUTICALS INC2003-10-07ANDA065151_001
3NDA050573SANDIMMUNENOVARTIS PHARMACEUTICALS CORP1983-11-14NDA050573_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065004_001RXCYCLOSPORINE (50MG/ML)INJECTIONFalseAP1999-10-29CYCLOSPORINE
2ANDA065151_001RXCYCLOSPORINE (50MG/ML)INJECTIONFalseAP2003-10-07CYCLOSPORINE
3NDA050573_001RXCYCLOSPORINE (50MG/ML)INJECTIONTrueAP1983-11-14SANDIMMUNE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
15977b562-3624-427c-bc64-b07247751b9e (view SPL)Cyclosporine Injection, USPprescriptionHuman PrescriptionPaddock Laboratories, LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-05-227005740866
25e5926a7-1de0-4b54-a5c0-286b6200ff82 (view SPL)Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) Sandimmune Oral Solution(cyclosporine oral solution, USP) Sandimmune Injection (cyclosporine injection, USP) FOR INFUSION ONLY Rx only Prescribing InformationprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-03-3117000780109, 000780110, 000780240, 000780241Cyclosporine Oral Capsule
Cyclosporine Oral Solution

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