Cyclosporine Oral Capsule

Brand(s)
Gengraf, Neoral, Sandimmune
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-03-31)
Oldest Current Product
1990-03-02
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\CYCLOSPORINE
FDAOB
ORAL\CAPSULE\CYCLOSPORINE
SPL Active
ORAL\CAPSULE, GELATIN COATED\CYCLOSPORINE
ORAL\CAPSULE, LIQUID FILLED\CYCLOSPORINE
ORAL\CAPSULE\CYCLOSPORINE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\CYCLOSPORINE
ORAL\CAPSULE, LIQUID FILLED\CYCLOSPORINE
ORAL\CAPSULE\CYCLOSPORINE

product(s) by strength(s)

cyclosporine 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780241SandimmuneNDANovartis Pharmaceuticals Corporation1990-03-02CYCLOSPORINEORALCAPSULE, LIQUID FILLEDNDA0506255e5926a7-1de0-4b54-a5c0-286b6200ff82

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1605050134ANDAApotex Corp2002-05-29CYCLOSPORINEORALCAPSULE, GELATIN COATEDANDA065040bfca7088-fe93-abb9-3ec3-e6f5710a69c6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685522ANDAPhysicians Total Care, Inc.2006-02-10CYCLOSPORINEORALCAPSULE, LIQUID FILLED605050134ANDA0650407014e788-a08a-46a2-a04a-2dd68f7201aa

cyclosporine 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780240SandimmuneNDANovartis Pharmaceuticals Corporation1990-03-02CYCLOSPORINEORALCAPSULE, LIQUID FILLEDNDA0506255e5926a7-1de0-4b54-a5c0-286b6200ff82

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1605050133ANDAApotex Corp2002-05-29CYCLOSPORINEORALCAPSULE, GELATIN COATEDANDA065040bfca7088-fe93-abb9-3ec3-e6f5710a69c6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840879ANDAAmerican Health Packaging2014-12-15CYCLOSPORINEORALCAPSULE, LIQUID FILLED605050133ANDA065040a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b

cyclosporine, modified 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780248NeoralNDANovartis Pharmaceuticals Corporation1995-07-14CYCLOSPORINEORALCAPSULE, LIQUID FILLEDNDA05071594461af3-11f1-4670-95d4-2965b9538ae3

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000746479GengrafANDAAbbvie Inc.2010-05-24CYCLOSPORINEORALCAPSULEANDA065003e896cbfe-4745-4088-82a3-8dc10b75c41f
2000935742ANDATeva Pharmaceuticals Usa Inc2015-06-01CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA0651102de1e8b1-625f-43ce-a1d5-d543be208b11
3001727312ANDAIvax Pharmaceuticals, Inc.2005-03-292017-03-31CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA0651109ef47270-a20d-417c-9c26-d5ea1b542b8a
4001850933ANDAEon Labs, Inc.2000-01-13CYCLOSPORINEORALCAPSULEANDA0650178893395a-6bfa-4b3c-84c2-d1d0c923304f
5005912223ANDAWatson Laboratories, Inc.2008-12-01CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA065044f7212224-52b7-447a-895c-880efafa551a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686232ANDAPhysicians Total Care, Inc.2011-02-10CYCLOSPORINEORALCAPSULE, LIQUID FILLED001727312ANDA065110893508f4-d20a-4511-94bb-b8f120734904
2551542395GengrafANDACardinal Health2010-05-24CYCLOSPORINEORALCAPSULE000746479ANDA06500395784b88-d570-41c1-8ee8-62fdcabdcbd5
3551546349ANDACardinal Health2010-09-01CYCLOSPORINEORALCAPSULE, LIQUID FILLED001727312ANDA065110b5580eb5-2f1c-44fb-aca6-138b872f249f
4680840921ANDAAmerican Health Packaging2015-03-30CYCLOSPORINEORALCAPSULE, LIQUID FILLED605050134ANDA065040a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b

cyclosporine, modified 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780246NeoralNDANovartis Pharmaceuticals Corporation1995-07-14CYCLOSPORINEORALCAPSULE, LIQUID FILLEDNDA05071594461af3-11f1-4670-95d4-2965b9538ae3

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000746463GengrafANDAAbbvie Inc.2010-05-24CYCLOSPORINEORALCAPSULEANDA065003e896cbfe-4745-4088-82a3-8dc10b75c41f
2000935740ANDATeva Pharmaceuticals Usa Inc2015-06-01CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA0651102de1e8b1-625f-43ce-a1d5-d543be208b11
3001727310ANDAIvax Pharmaceuticals, Inc.2005-03-292017-03-31CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA0651109ef47270-a20d-417c-9c26-d5ea1b542b8a
4001850932ANDAEon Labs, Inc.2000-01-13CYCLOSPORINEORALCAPSULEANDA0650178893395a-6bfa-4b3c-84c2-d1d0c923304f
5005912222ANDAWatson Laboratories, Inc.2008-12-01CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA065044f7212224-52b7-447a-895c-880efafa551a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551542396GengrafANDACardinal Health2010-05-24CYCLOSPORINEORALCAPSULE000746463ANDA06500395784b88-d570-41c1-8ee8-62fdcabdcbd5
2551543418NeoralNDACardinal Health1995-07-14CYCLOSPORINEORALCAPSULE, LIQUID FILLED000780246NDA0507158ea290c7-42d1-433a-ab75-c2e353442b62

cyclosporine, modified 50 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000935741ANDATeva Pharmaceuticals Usa Inc2015-06-01CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA0651102de1e8b1-625f-43ce-a1d5-d543be208b11
2001727311ANDAIvax Pharmaceuticals, Inc.2005-04-282017-02-28CYCLOSPORINEORALCAPSULE, LIQUID FILLEDANDA0651109ef47270-a20d-417c-9c26-d5ea1b542b8a

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA065003GENGRAFABBVIE INC2000-05-12ANDA065003_001, ANDA065003_002, ANDA065003_003
2ANDA065017CYCLOSPORINESANDOZ INC2000-01-13ANDA065017_001, ANDA065017_002
3ANDA065040CYCLOSPORINEAPOTEX INC2002-05-09ANDA065040_001, ANDA065040_002
4ANDA065044CYCLOSPORINEWATSON LABORATORIES INC2000-12-20ANDA065044_001, ANDA065044_002
5ANDA065110CYCLOSPORINEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2005-03-29ANDA065110_001, ANDA065110_002, ANDA065110_003
6NDA050625SANDIMMUNENOVARTIS PHARMACEUTICALS CORP1990-03-02NDA050625_001, NDA050625_002, NDA050625_003
7NDA050715NEORALNOVARTIS PHARMACEUTICALS CORP1995-07-14p5985321, SUBSTANCENDA050715_001, NDA050715_002, NDA050715_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065003_001RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB12000-05-12GENGRAF
2ANDA065003_002RXCYCLOSPORINE (50MG)ORALCAPSULEFalseAB12000-05-12GENGRAF
3ANDA065003_003RXCYCLOSPORINE (100MG)ORALCAPSULEFalseAB12000-05-12GENGRAF
4ANDA065017_001RXCYCLOSPORINE (100MG)ORALCAPSULEFalseAB12000-01-13CYCLOSPORINE
5ANDA065017_002RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB12000-01-13CYCLOSPORINE
6ANDA065040_001RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB22002-05-09CYCLOSPORINE
7ANDA065040_002RXCYCLOSPORINE (100MG)ORALCAPSULEFalseAB22002-05-09CYCLOSPORINE
8ANDA065044_001RXCYCLOSPORINE (100MG)ORALCAPSULEFalseAB12000-12-20CYCLOSPORINE
9ANDA065044_002RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB12000-12-20CYCLOSPORINE
10ANDA065110_001RXCYCLOSPORINE (50MG)ORALCAPSULEFalseAB12005-03-29CYCLOSPORINE
11ANDA065110_002RXCYCLOSPORINE (100MG)ORALCAPSULEFalseAB12005-03-29CYCLOSPORINE
12ANDA065110_003RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB12005-03-29CYCLOSPORINE
13NDA050625_001RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB21990-03-02SANDIMMUNE
14NDA050625_002RXCYCLOSPORINE (100MG)ORALCAPSULETrueAB21990-03-02SANDIMMUNE
15NDA050625_003RXCYCLOSPORINE (50MG)ORALCAPSULEFalseBX1992-11-23SANDIMMUNE
16NDA050715_001RXCYCLOSPORINE (25MG)ORALCAPSULEFalseAB11995-07-14NEORAL
17NDA050715_002RXCYCLOSPORINE (100MG)ORALCAPSULETrueAB11995-07-14NEORAL
18NDA050715_003discontinuedCYCLOSPORINE (50MG)ORALCAPSULEFalse1995-07-14NEORAL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5985321 (view patent)2014-09-26NDA050715, NDA050716Cyclosporine Oral Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12de1e8b1-625f-43ce-a1d5-d543be208b11 (view SPL)CycloSPORINE Capsules USP MODIFIED (Soft Gelatin Capsules)prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-202000935740, 000935741, 000935742
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 Corporation2015-03-3117000780240, 000780241, 000780109, 000780110Cyclosporine Injectable Solution
Cyclosporine Oral Solution
37014e788-a08a-46a2-a04a-2dd68f7201aa (view SPL)CYCLOSPORINE CAPSULES, USP 25 mg and 100 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-06-212548685522
48893395a-6bfa-4b3c-84c2-d1d0c923304f (view SPL)CycloSPORINE Capsules USP (Modified)prescriptionHuman PrescriptionEon Labs, Inc.2015-10-3019001850932, 001850933
5893508f4-d20a-4511-94bb-b8f120734904 (view SPL)CYCLOSPORINE CAPSULES USP MODIFIED (Soft Gelatin Capsules)Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-311548686232
68ea290c7-42d1-433a-ab75-c2e353442b62 (view SPL)NEORALSoft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED NEORALOral Solution (cyclosporine oral solution, USP) MODIFIED Rx only Prescribing InformationprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-084551543418
794461af3-11f1-4670-95d4-2965b9538ae3 (view SPL)NEORAL Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED NEORAL Oral Solution (cyclosporine oral solution, USP) MODIFIED Rx only Prescribing InformationprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-03-3115000780246, 000780248, 000780274Cyclosporine Oral Solution
895784b88-d570-41c1-8ee8-62fdcabdcbd5 (view SPL)GENGRAF Capsules (cyclosporine capsules USP [MODIFIED])prescriptionHuman PrescriptionCardinal HealthREPACK2015-01-286551542395, 551542396
99ef47270-a20d-417c-9c26-d5ea1b542b8a (view SPL)CycloSPORINE Capsules USP MODIFIED (Soft Gelatin Capsules)prescriptionHuman PrescriptionIvax Pharmaceuticals, Inc.2015-07-0713001727310, 001727311, 001727312
10a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b (view SPL)CYCLOSPORINE CAPSULES, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-173680840879, 680840921
11b5580eb5-2f1c-44fb-aca6-138b872f249f (view SPL)CYCLOSPORINE CAPSULES USP MODIFIED (Soft Gelatin Capsules)Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2012-04-091551546349
12bfca7088-fe93-abb9-3ec3-e6f5710a69c6 (view SPL)CYCLOSPORINE CAPSULES, USP 25 mg and 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionApotex Corp2015-05-257605050133, 605050134
13e896cbfe-4745-4088-82a3-8dc10b75c41f (view SPL)GENGRAF Capsules (cyclosporine capsules, USP [MODIFIED])prescriptionHuman PrescriptionAbbvie Inc.2015-06-121209000746463, 000746479
14f7212224-52b7-447a-895c-880efafa551a (view SPL)CyclosporineCapsules, USP [Modified](Soft Gelatin) Cyclosporine ORAL SOLUTION, USP [Modified] Revised: March 2014Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.2014-03-0111005912222, 005912223, 005912224Cyclosporine Oral Solution

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