Application 020827

Type
NDA
Sponsor
MEDTECH PRODUCTS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MONISTAT 3MICONAZOLE NITRATECREAM;VAGINAL4%YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
63736-015Monistat 3Miconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-015Monistat 3Miconazole NitrateInsight PharmaceuticalsNDACurrent

Documents

DocumentSubmission typeDate
68915SUPPL2021-10-08
61723SUPPL2020-01-29
61722SUPPL2020-01-29
49514SUPPL2017-08-22
25936SUPPL2009-11-10
25935SUPPL2008-09-09
3440SUPPL2002-08-07
41724ORIG1998-03-30
25934ORIG1998-03-30
13502ORIG1998-03-30