FDA.reportPublic FDA data

Application 022404

Type
NDA
Sponsor
FORTOVIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORAVIGMICONAZOLETABLET;BUCCAL50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61825-303OravigMiconazoleGalt Pharmaceuticals, LLCNDACurrent
89141-250ORAVIGmiconazoleMidatech Pharma US, Inc.NDACurrent
89141-250ORAVIGmiconazoleMidatech Pharma US, Inc.NDACurrent
89141-250ORAVIGmiconazoleMidatech Pharma US, Inc.NDACurrent
89141-250ORAVIGmiconazoleMidatech Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61781SUPPL2020-02-05
61777SUPPL2020-02-05
17324SUPPL2013-03-08
29687SUPPL2013-03-06
29686SUPPL2011-04-13
38662SUPPL2011-04-11
24297ORIG2010-12-23
22012ORIG2010-12-23
29685ORIG2010-05-03
17323ORIG2010-05-03