FDA.reportPublic FDA data

Application 021535

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBEXCLOBETASOL PROPIONATELOTION;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-3848ClobexClobetasol PropionateGalderma Laboratories, L.P.NDACurrent
0574-2103Clobetasol PropionateClobetasol PropionatePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-2103Clobetasol PropionateClobetasol PropionatePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-2103Clobetasol PropionateClobetasol PropionatePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15712SUPPL2014-01-14
5668SUPPL2012-12-03
28048SUPPL2012-08-20
15711SUPPL2012-08-20
21721ORIG2004-06-14
28047ORIG2003-07-28
15710ORIG2003-07-28