FDA.reportPublic FDA data

Application 019964

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERAZOL 3TERCONAZOLECREAM;VAGINAL0.8%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3197TERCONAZOLETERCONAZOLEActavis Pharma, IncNDA AUTHORIZED GENERICCurrent
21695-933TERCONAZOLEterconazoleRebel Distributors CorpNDACurrent
50458-536Terazol 3TERCONAZOLEJanssen Pharmaceuticals, Inc.NDACurrent
55045-3259TERCONAZOLEterconazoleDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1875SUPPL2014-07-25
34164SUPPL2014-07-24
1874SUPPL2013-10-01
34163SUPPL2013-09-27
12111SUPPL2004-07-01
19909SUPPL2004-06-30
1873SUPPL2003-09-30
1872SUPPL2003-03-25
1871SUPPL2003-03-25
34162SUPPL2003-03-20
12110SUPPL2003-03-20