FDA.reportPublic FDA data

Application 210361

Type
NDA
Sponsor
DERMIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QBREXZAGLYCOPYRRONIUM TOSYLATECLOTH;TOPICALEQ 2.4% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69489-411QbrexzaglycopyrroniumJourney Medical CorporationNDACurrent
69489-411QbrexzaglycopyrroniumJourney Medical CorporationNDACurrent
69489-411QbrexzaglycopyrroniumJourney Medical CorporationNDACurrent
70428-011QbrexzaglycopyrroniumDermira, Inc.NDACurrent
70428-011QbrexzaglycopyrroniumDermira, Inc.NDACurrent
70428-011QbrexzaglycopyrroniumJourney Medical CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72525SUPPL2022-11-01
72504SUPPL2022-10-31
70694SUPPL2022-04-05
70680SUPPL2022-04-04
56528ORIG2018-11-20
54958ORIG2018-07-24
54748ORIG2018-07-05
63064ORIG1900-01-01