FDA.reportPublic FDA data

Application 206255

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOOLANTRAIVERMECTINCREAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-3823SOOLANTRAIVERMECTINGalderma Laboratories, L.P.NDACurrent
0299-3823SOOLANTRAIVERMECTINGalderma Laboratories, L.P.NDACurrent
0299-3823SOOLANTRAIVERMECTINGalderma Laboratories, L.P.NDACurrent
0574-2107IvermectinIVERMECTINPadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-2107IvermectinIVERMECTINPaddock Laboratories, LLC.NDA AUTHORIZED GENERICCurrent
0574-2107IvermectinIVERMECTINPaddock Laboratories, LLC.NDA AUTHORIZED GENERICCurrent
66993-948IvermectinIVERMECTINPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-948IvermectinIVERMECTINPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72396SUPPL2022-10-17
72395SUPPL2022-10-17
72355SUPPL2022-10-17
72354SUPPL2022-10-17
53785SUPPL2018-04-23
53748SUPPL2018-04-20
24512ORIG2016-03-23
23016ORIG2016-03-23
40531ORIG2015-01-08
10553ORIG2014-12-24