Cyclosporine Oral Solution

Brand(s)
Gengraf, Neoral, 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
ORAL SOLUTION\CYCLOSPORINE
FDAOB
ORAL\SOLUTION\CYCLOSPORINE
SPL Active
ORAL\SOLUTION\CYCLOSPORINE
SPL Moiety
ORAL\SOLUTION\CYCLOSPORINE

product(s) by strength(s)

cyclosporine 100 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780110SandimmuneNDANovartis Pharmaceuticals Corporation1983-11-14CYCLOSPORINEORALSOLUTIONNDA0505745e5926a7-1de0-4b54-a5c0-286b6200ff82

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1604320140ANDAMorton Grove Pharmaceuticals, Inc.2005-02-09CYCLOSPORINEORALSOLUTIONANDA0651333a5bb208-10c3-41a3-8638-75409c554201

cyclosporine, modified 100 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780274NeoralNDANovartis Pharmaceuticals Corporation1995-07-14CYCLOSPORINEORALSOLUTIONNDA05071694461af3-11f1-4670-95d4-2965b9538ae3

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000747269GengrafANDAAbbvie Inc.2010-05-25CYCLOSPORINEORALSOLUTIONANDA06502529891f95-9079-4880-7abc-194e49767dd5
2001727313ANDAIvax Pharmaceuticals, Inc.2005-03-29CYCLOSPORINEORALSOLUTIONANDA065078f3dc2a50-1084-4190-a6f3-37034a04db86
3005912224ANDAWatson Laboratories, Inc.2008-12-01CYCLOSPORINEORALSOLUTIONANDA065054f7212224-52b7-447a-895c-880efafa551a

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA065025CYCLOSPORINEABBVIE INC2000-03-03ANDA065025_001
2ANDA065054CYCLOSPORINEWATSON LABORATORIES INC2001-12-18ANDA065054_001
3ANDA065078CYCLOSPORINEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2005-03-25ANDA065078_001
4ANDA065133CYCLOSPORINEWOCKHARDT EU OPERATIONS (SWISS) AG2004-09-17ANDA065133_001
5ANDA065167CYCLOSPORINETrueAPOTEX INC2005-01-05ANDA065167_001
6NDA050574SANDIMMUNENOVARTIS PHARMACEUTICALS CORP1983-11-14NDA050574_001
7NDA050716NEORALNOVARTIS PHARMACEUTICALS CORP1995-07-14p5985321, SUBSTANCENDA050716_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065025_001RXCYCLOSPORINE (100MG/ML)ORALSOLUTIONFalseAB12000-03-03CYCLOSPORINE
2ANDA065054_001RXCYCLOSPORINE (100MG/ML)ORALSOLUTIONFalseAB12001-12-18CYCLOSPORINE
3ANDA065078_001RXCYCLOSPORINE (100MG/ML)ORALSOLUTIONFalseAB12005-03-25CYCLOSPORINE
4ANDA065133_001RXCYCLOSPORINE (100MG/ML)ORALSOLUTIONFalseAB22004-09-17CYCLOSPORINE
5ANDA065167_001discontinuedCYCLOSPORINE (100MG/ML)ORALSOLUTIONFalse2005-01-05CYCLOSPORINE
6NDA050574_001RXCYCLOSPORINE (100MG/ML)ORALSOLUTIONTrueAB21983-11-14SANDIMMUNE
7NDA050716_001RXCYCLOSPORINE (100MG/ML)ORALSOLUTIONTrueAB11995-07-14NEORAL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5985321 (view patent)2014-09-26NDA050716, NDA050715Cyclosporine Oral Capsule

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
129891f95-9079-4880-7abc-194e49767dd5 (view SPL)GENGRAF ORAL SOLUTION(cyclosporine oral solution, USP [MODIFIED])prescriptionHuman PrescriptionAbbvie Inc.2015-06-161207000747269
23a5bb208-10c3-41a3-8638-75409c554201 (view SPL)CYCLOSPORINE ORAL SOLUTION, USP 100 mg/mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2010-06-253604320140
35e5926a7-1de0-4b54-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 Corporation2015-03-3117000780110, 000780109, 000780240, 000780241Cyclosporine Injectable Solution
Cyclosporine Oral Capsule
494461af3-11f1-4670-95d4-2965b9538ae3 (view SPL)NEORAL Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED NEORAL Oral Solution (cyclosporine oral solution, USP) MODIFIED Rx only Prescribing InformationprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-03-3115000780274, 000780246, 000780248Cyclosporine Oral Capsule
5f3dc2a50-1084-4190-a6f3-37034a04db86 (view SPL)CycloSPORINE Oral Solution USP MODIFIEDprescriptionHuman PrescriptionIvax Pharmaceuticals, Inc.2015-07-2412001727313
6f7212224-52b7-447a-895c-880efafa551a (view SPL)CyclosporineCapsules, USP [Modified](Soft Gelatin) Cyclosporine ORAL SOLUTION, USP [Modified] Revised: March 2014Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.2014-03-0111005912224, 005912222, 005912223Cyclosporine Oral Capsule

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