Fluconazole Oral Suspension

Brand(s)
Diflucan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2014-12-04)
Oldest Current Product
1993-12-23
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\FLUCONAZOLE
FDAOB
ORAL\FOR SUSPENSION\FLUCONAZOLE
SPL Active
ORAL\POWDER, FOR SUSPENSION\FLUCONAZOLE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\FLUCONAZOLE

product(s) by strength(s)

fluconazole 10 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000493440DiflucanNDARoerig1993-12-23FLUCONAZOLEORALPOWDER, FOR SUSPENSIONNDA020090f694c617-3383-416c-91b6-b94fda371204

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540002ANDARoxane Laboratories, Inc2004-07-29FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA076246bf92a7d7-395b-4e2c-a3c4-66ebdbfd1052
2000935414ANDATeva Pharmaceuticals Usa Inc2008-09-22FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA07752329bd0efa-fb16-4e69-bb96-8f6bcf80b9f7
3167140695ANDANorthstar Rx Llc2009-09-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA079150afde17e7-b95b-4cd5-97eb-e361724014bd
4572370149ANDACitron Pharma Llc2009-09-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA079150ccbe0991-27a1-4ddb-bfc7-1b3422e53390
5597625029NDA AUTHORIZED GENERICGreenstone Llc1993-12-23FLUCONAZOLEORALPOWDER, FOR SUSPENSIONNDA020090737e0fac-a2d2-4053-a0d7-edbfb6248f69
6658620299ANDAAurobindo Pharma Limited2009-09-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA079150bf588f7e-89de-4b4e-8d33-c1ff2be1b34e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724088ANDATaro Pharmaceuticals U.S.A., Inc.2006-12-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA07691808afda78-eb23-4c0e-ba02-690598e5af9c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685248NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2005-03-11FLUCONAZOLEORALPOWDER, FOR SUSPENSION597625029NDA020090926100a4-98b2-40ec-8592-56f86fa0cf22

fluconazole 40 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000493450DiflucanNDARoerig1993-12-23FLUCONAZOLEORALPOWDER, FOR SUSPENSIONNDA020090f694c617-3383-416c-91b6-b94fda371204

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540003ANDARoxane Laboratories, Inc2004-07-29FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA076246bf92a7d7-395b-4e2c-a3c4-66ebdbfd1052
2000935415ANDATeva Pharmaceuticals Usa Inc2008-09-22FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA07752329bd0efa-fb16-4e69-bb96-8f6bcf80b9f7
3167140696ANDANorthstar Rx Llc2009-09-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA079150afde17e7-b95b-4cd5-97eb-e361724014bd
4572370150ANDACitron Pharma Llc2009-09-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA079150ccbe0991-27a1-4ddb-bfc7-1b3422e53390
5597625030NDA AUTHORIZED GENERICGreenstone Llc1993-12-23FLUCONAZOLEORALPOWDER, FOR SUSPENSIONNDA020090737e0fac-a2d2-4053-a0d7-edbfb6248f69
6658620300ANDAAurobindo Pharma Limited2009-09-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA079150bf588f7e-89de-4b4e-8d33-c1ff2be1b34e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724089ANDATaro Pharmaceuticals U.S.A., Inc.2006-12-18FLUCONAZOLEORALPOWDER, FOR SUSPENSIONANDA07691808afda78-eb23-4c0e-ba02-690598e5af9c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686116NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2010-04-27FLUCONAZOLEORALPOWDER, FOR SUSPENSION597625030NDA020090926100a4-98b2-40ec-8592-56f86fa0cf22

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076246FLUCONAZOLEROXANE LABORATORIES INC2004-07-29ANDA076246_001, ANDA076246_002
2ANDA076332FLUCONAZOLESUN PHARMACEUTICAL INDUSTRIES LTD2004-07-29ANDA076332_001, ANDA076332_002
3ANDA076918FLUCONAZOLETrueTARO PHARMACEUTICAL INDUSTRIES LTD2006-12-18ANDA076918_001, ANDA076918_002
4ANDA077523FLUCONAZOLEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2007-09-12ANDA077523_001, ANDA077523_002
5ANDA079150FLUCONAZOLEAUROBINDO PHARMA USA INC2009-09-18ANDA079150_001, ANDA079150_002
6NDA020090DIFLUCANPFIZER CHEMICALS DIV PFIZER INC1993-12-23NDA020090_001, NDA020090_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076246_001RXFLUCONAZOLE (50MG/5ML)ORALFOR SUSPENSIONFalseAB2004-07-29FLUCONAZOLE
2ANDA076246_002RXFLUCONAZOLE (200MG/5ML)ORALFOR SUSPENSIONFalseAB2004-07-29FLUCONAZOLE
3ANDA076332_001RXFLUCONAZOLE (50MG/5ML)ORALFOR SUSPENSIONFalseAB2004-07-29FLUCONAZOLE
4ANDA076332_002RXFLUCONAZOLE (200MG/5ML)ORALFOR SUSPENSIONFalseAB2004-07-29FLUCONAZOLE
5ANDA076918_001discontinuedFLUCONAZOLE (50MG/5ML)ORALFOR SUSPENSIONFalse2006-12-18FLUCONAZOLE
6ANDA076918_002discontinuedFLUCONAZOLE (200MG/5ML)ORALFOR SUSPENSIONFalse2006-12-18FLUCONAZOLE
7ANDA077523_001RXFLUCONAZOLE (50MG/5ML)ORALFOR SUSPENSIONFalseAB2007-09-12FLUCONAZOLE
8ANDA077523_002RXFLUCONAZOLE (200MG/5ML)ORALFOR SUSPENSIONFalseAB2007-09-12FLUCONAZOLE
9ANDA079150_001RXFLUCONAZOLE (50MG/5ML)ORALFOR SUSPENSIONFalseAB2009-09-18FLUCONAZOLE
10ANDA079150_002RXFLUCONAZOLE (200MG/5ML)ORALFOR SUSPENSIONFalseAB2009-09-18FLUCONAZOLE
11NDA020090_001RXFLUCONAZOLE (50MG/5ML)ORALFOR SUSPENSIONFalseAB1993-12-23DIFLUCAN
12NDA020090_002RXFLUCONAZOLE (200MG/5ML)ORALFOR SUSPENSIONTrueAB1993-12-23DIFLUCAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
108afda78-eb23-4c0e-ba02-690598e5af9c (view SPL)Fluconazole for Oral SuspensionprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-12-096516724088, 516724089
229bd0efa-fb16-4e69-bb96-8f6bcf80b9f7 (view SPL)Fluconazole for Oral SuspensionprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-07-196000935414, 000935415
3737e0fac-a2d2-4053-a0d7-edbfb6248f69 (view SPL)FLUCONAZOLE Fluconazole Tablets Fluconazole for Oral SuspensionprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-0417597625029, 597625030, 597625015, 597625016, 597625017, 597625018Fluconazole Oral Tablet
4926100a4-98b2-40ec-8592-56f86fa0cf22 (view SPL)FLUCONAZOLE Fluconazole Tablets Fluconazole for Oral SuspensionprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-11-2713548685248, 548686116, 548685129, 548685144, 548685345Fluconazole Oral Tablet
5afde17e7-b95b-4cd5-97eb-e361724014bd (view SPL)Fluconazole for Oral Suspension USPRx OnlyprescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-03-246167140695, 167140696
6bf588f7e-89de-4b4e-8d33-c1ff2be1b34e (view SPL)Fluconazole for Oral Suspension USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-0812658620299, 658620300
7bf92a7d7-395b-4e2c-a3c4-66ebdbfd1052 (view SPL)prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-01-017000540002, 000540003
8ccbe0991-27a1-4ddb-bfc7-1b3422e53390 (view SPL)Fluconazole for Oral Suspension USPRx onlyprescriptionHuman PrescriptionCitron Pharma Llc2015-09-101572370149, 572370150
9f694c617-3383-416c-91b6-b94fda371204 (view SPL)DIFLUCAN (Fluconazole Tablets) (Fluconazole for Oral Suspension)prescriptionHuman PrescriptionRoerigANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-11-1122000493440, 000493450, 000493410, 000493420, 000493430, 000493500Fluconazole Oral Tablet

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