FDA.report

Application 017450

Type
NDA
Sponsor
MEDTECH PRODUCTS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
002MONISTAT 7MICONAZOLE NITRATECREAM;VAGINAL2%YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
63736-003Monistat 7 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-023Monistat 7 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-023Monistat 7 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-025Monistat 7Miconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-025Monistat 7Miconazole NitrateInsight PharmaceuticalsNDACurrent
63736-026MONISTAT 7Miconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-026Monistat 7Miconazole NitrateInsight PharmaceuticalsNDACurrent

Documents

DocumentSubmission typeDate
70539SUPPL2022-03-17
70397SUPPL2022-03-04
61719SUPPL2020-01-29
61718SUPPL2020-01-29
50145SUPPL2017-10-23
49515SUPPL2017-08-22
590SUPPL2008-08-22
33271SUPPL2002-08-07
13143SUPPL2002-08-07