Diflorasone Topical Ointment

Brand(s)
Apexicon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Taro Pharmaceuticals U.S.A., Inc. (2015-06-26)
Oldest Current Product
1999-04-27
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\DIFLORASONE
FDAOB
TOPICAL\OINTMENT\DIFLORASONE DIACETATE
SPL Active
TOPICAL\OINTMENT\DIFLORASONE DIACETATE
SPL Moiety
TOPICAL\OINTMENT\DIFLORASONE
TOPICAL\OINTMENT\DIFLORASONE DIACETATE

product(s) by strength(s)

diflorasone diacetate 0.0005 mg/mg topical ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680243ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1999-04-27DIFLORASONE DIACETATETOPICALOINTMENTANDA0753745b92dbac-3f28-4c72-b529-7455e1b7b366
2004620394ApexiconANDAPharmaderm, A Division Of Nycomed Us Inc.2009-09-30DIFLORASONE DIACETATETOPICALOINTMENTANDA075374a44f7c47-1fe7-4f5a-8bef-6df192c3357c
3516721295ANDATaro Pharmaceuticals U.S.A., Inc.1999-05-14DIFLORASONE DIACETATETOPICALOINTMENTANDA075331b304dfca-e840-4c03-8217-73aaa5360277

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075331DIFLORASONE DIACETATETARO PHARMACEUTICALS INC1999-05-14ANDA075331_001
2ANDA075374DIFLORASONE DIACETATEFOUGERA PHARMACEUTICALS INC1999-04-27ANDA075374_001
3ANDA206572DIFLORASONE DIACETATEVERSAPHARM INC2015-07-24ANDA206572_001
4NDA017994PSORCON ETruePHARMACIA AND UPJOHN CONDA017994_001
5NDA019260PSORCONTruePHARMACIA AND UPJOHN CO1985-08-28NDA019260_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075331_001RXDIFLORASONE DIACETATE (0.05%)TOPICALOINTMENTTrueAB1999-05-14DIFLORASONE DIACETATE
2ANDA075374_001RXDIFLORASONE DIACETATE (0.05%)TOPICALOINTMENTFalseAB1999-04-27DIFLORASONE DIACETATE
3ANDA206572_001RXDIFLORASONE DIACETATE (0.05%)TOPICALOINTMENTFalseAB2015-07-24DIFLORASONE DIACETATE
4NDA017994_001discontinuedDIFLORASONE DIACETATE (0.05%)TOPICALOINTMENTFalsePSORCON E
5NDA019260_001discontinuedDIFLORASONE DIACETATE (0.05%)TOPICALOINTMENTFalse1985-08-28PSORCON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15b92dbac-3f28-4c72-b529-7455e1b7b366 (view SPL)DIFLORASONE DIACETATE OINTMENT USP, 0.05%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-08-126001680243
2a44f7c47-1fe7-4f5a-8bef-6df192c3357c (view SPL)ApexiCon Ointment(diflorasone diacetate ointment, USP, 0.05%)prescriptionHuman PrescriptionPharmaderm, A Division Of Nycomed Us Inc.ANALYSIS, MANUFACTURE2009-09-302004620394
3b304dfca-e840-4c03-8217-73aaa5360277 (view SPL)Diflorasone Diacetate Ointment USP, 0.05%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-06-263516721295

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