FDA.reportPublic FDA data

Application 019579

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERAZOL 7TERCONAZOLECREAM;VAGINAL0.4%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3196TERCONAZOLETERCONAZOLEActavis Pharma, IncNDA AUTHORIZED GENERICCurrent
50090-2341TERCONAZOLETERCONAZOLEA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50458-535Terazol 7TERCONAZOLEJanssen Pharmaceuticals, Inc.NDACurrent
50458-535Terazol 7TERCONAZOLEJanssen Pharmaceuticals, Inc.NDACurrent
52959-811TERCONAZOLEterconazoleH.J. Harkins Company, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17464SUPPL2014-07-25
11541SUPPL2014-07-24
1397SUPPL2013-10-01
33802SUPPL2013-09-27
11540SUPPL2004-07-01
17463SUPPL2004-06-30
17462SUPPL2003-09-30
17461SUPPL2003-03-25
1396SUPPL2003-03-25
33801SUPPL2003-03-20
11539SUPPL2003-03-20