fluticasone Topical Ointment

Brand(s)
Cutivate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaderm A Division Of Fougera Pharmaceuticals Inc. (2015-02-15)
Oldest Current Product
2004-05-14
License(s)
NDA, ANDA
RxNORM
TOPICAL OINTMENT\FLUTICASONE
FDAOB
TOPICAL\OINTMENT\FLUTICASONE PROPIONATE
SPL Active
TOPICAL\OINTMENT\FLUTICASONE PROPIONATE
SPL Moiety
TOPICAL\OINTMENT\FLUTICASONE

product(s) by strength(s)

fluticasone propionate 0.00005 mg/mg topical ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1103370333CutivateNDAPharmaderm A Division Of Fougera Pharmaceuticals Inc.2009-12-14FLUTICASONE PROPIONATETOPICALOINTMENTNDA019957c0c8cd3b-e44b-4639-8f5a-65c447d50178

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680333ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2004-05-14FLUTICASONE PROPIONATETOPICALOINTMENTANDA07630004d2a675-a9c6-4dce-b17d-dfc86865f8e1
2007130632ANDAG&W Laboratories, Inc.2006-05-31FLUTICASONE PROPIONATETOPICALOINTMENTANDA077168e7ef2aaf-749c-66c9-2bdf-7214ab00060e
3458020221ANDAPerrigo New York Inc2007-07-09FLUTICASONE PROPIONATETOPICALOINTMENTANDA07666816985600-3f81-4d51-8bf7-0cbbd89856a1

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724095ANDATaro Pharmaceuticals U.S.A., Inc.2005-06-14FLUTICASONE PROPIONATETOPICALOINTMENTANDA077145ff96762d-a841-4558-befd-d14761bbe6fc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685458ANDAPhysicians Total Care, Inc.2005-10-20FLUTICASONE PROPIONATETOPICALOINTMENT458020221ANDA076668255e71b4-9e24-4ad2-93f6-0a0ade71d823

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076300FLUTICASONE PROPIONATEFOUGERA PHARMACEUTICALS INC2004-05-14ANDA076300_001
2ANDA076668FLUTICASONE PROPIONATEPERRIGO NEW YORK INC2004-05-14ANDA076668_001
3ANDA077145FLUTICASONE PROPIONATETrueTARO PHARMACEUTICAL INDUSTRIES LTD2005-06-14ANDA077145_001
4ANDA077168FLUTICASONE PROPIONATEG AND W LABORATORIES INC2006-03-03ANDA077168_001
5NDA019957CUTIVATEFOUGERA PHARMACEUTICALS INC1990-12-14NDA019957_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076300_001RXFLUTICASONE PROPIONATE (0.005%)TOPICALOINTMENTFalseAB2004-05-14FLUTICASONE PROPIONATE
2ANDA076668_001RXFLUTICASONE PROPIONATE (0.005%)TOPICALOINTMENTFalseAB2004-05-14FLUTICASONE PROPIONATE
3ANDA077145_001discontinuedFLUTICASONE PROPIONATE (0.005%)TOPICALOINTMENTFalse2005-06-14FLUTICASONE PROPIONATE
4ANDA077168_001RXFLUTICASONE PROPIONATE (0.005%)TOPICALOINTMENTFalseAB2006-03-03FLUTICASONE PROPIONATE
5NDA019957_001RXFLUTICASONE PROPIONATE (0.005%)TOPICALOINTMENTTrueAB1990-12-14CUTIVATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104d2a675-a9c6-4dce-b17d-dfc86865f8e1 (view SPL)FLUTICASONE PROPIONATE OINTMENT, 0.005%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2012-05-172001680333
216985600-3f81-4d51-8bf7-0cbbd89856a1 (view SPL)Fluticasone Propionate Ointment, 0.005%prescriptionHuman PrescriptionPerrigo New York Inc2015-10-135458020221
3255e71b4-9e24-4ad2-93f6-0a0ade71d823 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-202548685458
4c0c8cd3b-e44b-4639-8f5a-65c447d50178 (view SPL)These highlights do not include all the information needed to use CUTIVATE Ointment safely and effectively. See full prescribing information for CUTIVATE Ointment. CUTIVATE (fluticasone propionate) Ointment, 0.005%, for topical use Initial U.S. Approval: 1990prescriptionHuman PrescriptionPharmaderm A Division Of Fougera Pharmaceuticals Inc.2015-02-151103370333
5e7ef2aaf-749c-66c9-2bdf-7214ab00060e (view SPL)FLUTICASONE PROPIONATEOINTMENT, 0.005%For Dermatologic Use Only-Not for Ophthalmic UseRx OnlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2008-09-041007130632
6ff96762d-a841-4558-befd-d14761bbe6fc (view SPL)FLUTICASONE PROPIONATE OINTMENT, 0.005%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-07-192516724095

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