FDA.reportPublic FDA data

Application 205223

Type
NDA
Sponsor
CHEMO RESEARCH SL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUVESSAMETRONIDAZOLEGEL;VAGINAL1.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent
0642-7466NuvessametronidazoleExeltis USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70319SUPPL2022-03-01
70291SUPPL2022-02-28
69542SUPPL2021-12-14
69505SUPPL2021-12-07
63175ORIG2020-05-20
55127SUPPL2018-08-07
55120SUPPL2018-08-06
43485ORIG2014-10-07
24490ORIG2014-10-07
40456ORIG2014-03-25
10432ORIG2014-03-25
63174ORIG1900-01-01
63173ORIG1900-01-01