FDA.reportPublic FDA data

Application 212379

Type
NDA
Sponsor
FOAMIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMZEEQMINOCYCLINE HYDROCHLORIDEAEROSOL, FOAM;TOPICALEQ 4% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69489-201AMZEEQMinocyclineJourney Medical CorporationNDACurrent
72356-101AMZEEQMinocyclineJourney Medical CorporationNDACurrent
72356-101AMZEEQMinocyclineVYNE Pharmaceuticals Inc.NDACurrent
72356-101AMZEEQMinocyclineJourney Medical CorporationNDACurrent
72356-101AMZEEQMinocyclineVYNE Pharmaceuticals Inc.NDACurrent
72356-101AMZEEQMinocyclineJourney Medical CorporationNDACurrent
72356-101AMZEEQMinocyclineJourney Medical CorporationNDACurrent
72356-101AMZEEQMinocyclineVYNE Pharmaceuticals Inc.NDACurrent
72356-101AMZEEQMinocyclineFoamix Pharmaceuticals Inc.NDACurrent
72356-101AMZEEQMinocyclineFoamix Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70396SUPPL2022-03-03
70239SUPPL2022-02-24
66053SUPPL2021-02-01
66038SUPPL2021-02-01
62519ORIG2020-04-09
60621ORIG2019-10-22
60606ORIG2019-10-21