halobetasol Topical Ointment

Brand(s)
Ultravate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ranbaxy Laboratories Inc (2012-08-13)
Oldest Current Product
2004-12-16
License(s)
NDA, ANDA
RxNORM
TOPICAL OINTMENT\HALOBETASOL
FDAOB
TOPICAL\OINTMENT\HALOBETASOL PROPIONATE
SPL Active
TOPICAL\OINTMENT\HALOBETASOL PROPIONATE
SPL Moiety
TOPICAL\OINTMENT\HALOBETASOL

product(s) by strength(s)

halobetasol propionate 0.0005 mg/mg topical ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1106310102UltravateNDARanbaxy Laboratories Inc2009-02-20HALOBETASOL PROPIONATETOPICALOINTMENTNDA019968031f1120-7da1-4ea6-a0be-d368018e2c1f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130639ANDAG&W Laboratories, Inc.2007-04-27HALOBETASOL PROPIONATETOPICALOINTMENTANDA0777217f22c10f-2691-a0a5-901e-a7c0fe41611f
2458020131ANDAPerrigo New York Inc2009-02-05HALOBETASOL PROPIONATETOPICALOINTMENTANDA076872c420da92-a3e3-4760-8cad-e50cbacebfeb
3516721322ANDATaro Pharmaceuticals U.S.A., Inc.2004-12-16HALOBETASOL PROPIONATETOPICALOINTMENTANDA0769941b3fd144-9ebd-46b0-b240-8bca47d101cd

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680356ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2004-12-16HALOBETASOL PROPIONATETOPICALOINTMENTANDA076903dd9e2429-2e28-4f53-9b26-0ebb7f61c5c4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1529590961ANDAH.J. Harkins Company, Inc.2009-02-05HALOBETASOL PROPIONATETOPICALOINTMENT458020131ANDA076872b840b012-ef8e-4637-8e48-b1c867e7a050
2548685482ANDAPhysicians Total Care, Inc.2005-12-05HALOBETASOL PROPIONATETOPICALOINTMENT458020131ANDA076872f5304f1d-8e0d-4040-becf-ed1abf5faaa4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076872HALOBETASOL PROPIONATEPERRIGO CO2004-12-16ANDA076872_001
2ANDA076903HALOBETASOL PROPIONATETrueFOUGERA PHARMACEUTICALS INC2004-12-16ANDA076903_001
3ANDA076994HALOBETASOL PROPIONATETARO PHARMACEUTICALS USA INC2004-12-16ANDA076994_001
4ANDA077109HALOBETASOL PROPIONATETrueG AND W LABORATORIES INC2005-06-14ANDA077109_001
5ANDA077721HALOBETASOL PROPIONATEG AND W LABORATORIES INC2006-09-07ANDA077721_001
6NDA019968ULTRAVATERANBAXY LABORATORIES INC1990-12-17NDA019968_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076872_001RXHALOBETASOL PROPIONATE (0.05%)TOPICALOINTMENTFalseAB2004-12-16HALOBETASOL PROPIONATE
2ANDA076903_001discontinuedHALOBETASOL PROPIONATE (0.05%)TOPICALOINTMENTFalse2004-12-16HALOBETASOL PROPIONATE
3ANDA076994_001RXHALOBETASOL PROPIONATE (0.05%)TOPICALOINTMENTFalseAB2004-12-16HALOBETASOL PROPIONATE
4ANDA077109_001discontinuedHALOBETASOL PROPIONATE (0.05%)TOPICALOINTMENTFalse2005-06-14HALOBETASOL PROPIONATE
5ANDA077721_001RXHALOBETASOL PROPIONATE (0.05%)TOPICALOINTMENTFalseAB2006-09-07HALOBETASOL PROPIONATE
6NDA019968_001RXHALOBETASOL PROPIONATE (0.05%)TOPICALOINTMENTTrueAB1990-12-17ULTRAVATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1031f1120-7da1-4ea6-a0be-d368018e2c1f (view SPL)Ultravate (halobetasol propionate) Cream, 0.05%(halobetasol propionate) Ointment, 0.05%For Dermatological Use Only. Not for Ophthalmic Use.Rx onlyprescriptionHuman PrescriptionRanbaxy Laboratories Incapi manufacture, manufacture, pack2012-08-133106310102, 106310103halobetasol Topical Cream
21b3fd144-9ebd-46b0-b240-8bca47d101cd (view SPL)Halobetasol Propionate Ointment, 0.05%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-06-053516721322
37f22c10f-2691-a0a5-901e-a7c0fe41611f (view SPL)Halobetasol Propionate Ointment, 0.05%For Dermatological Use Only. Not for Ophthalmic UseRx OnlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2009-02-193007130639
4b840b012-ef8e-4637-8e48-b1c867e7a050 (view SPL)HALOBETASOL PROPIONATE OINTMENT, 0.05%prescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-12-022529590961
5c420da92-a3e3-4760-8cad-e50cbacebfeb (view SPL)HALOBETASOL PROPIONATE OINTMENT, 0.05%prescriptionHuman PrescriptionPerrigo New York Inc2009-02-052458020131
6dd9e2429-2e28-4f53-9b26-0ebb7f61c5c4 (view SPL)HALOBETASOL PROPIONATE OINTMENT, 0.05%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2013-02-066001680356
7f5304f1d-8e0d-4040-becf-ed1abf5faaa4 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-10-271548685482

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