Application 204141

Type
NDA
Sponsor
TARO PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPICORTDESOXIMETASONESPRAY;TOPICAL0.25%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51672-1396DesoximetasoneDesoximetasoneTaro Pharmaceuticals U.S.A., Inc.NDA AUTHORIZED GENERICCurrent
51672-1396DesoximetasoneDesoximetasoneTaro Pharmaceuticals U.S.A., Inc.NDA AUTHORIZED GENERICCurrent
51672-5281TopicortDesoximetasoneTaro Pharmaceuticals U.S.A., Inc.NDACurrent
51672-5281TopicortDesoximetasoneTaro Pharmaceuticals U.S.A., Inc.NDACurrent
51672-5281TopicortDesoximetasoneTaro Pharmaceuticals U.S.A., Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68976SUPPL2021-10-13
68952SUPPL2021-10-12
32516SUPPL2015-12-17
19530SUPPL2015-12-17
44896ORIG2013-11-05
22944ORIG2013-11-05
40357ORIG2013-04-16
32515ORIG2013-04-16