FDA.reportPublic FDA data

Application 019555

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPROLENE AFBETAMETHASONE DIPROPIONATECREAM, AUGMENTED;TOPICALEQ 0.05% BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-0517DIPROLENE AFbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0517DIPROLENE AFbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0517DIPROLENE AFbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0517DIPROLENE AFbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0517DIPROLENE AFbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58526SUPPL2019-05-02
58522SUPPL2019-05-02
53586SUPPL2018-04-01
53569SUPPL2018-04-01
11528SUPPL2014-08-15
17452SUPPL2014-08-14
17451SUPPL2006-09-18
33798SUPPL2006-08-28
33797SUPPL2001-10-03
33796SUPPL2001-10-03
20260SUPPL2001-10-03
20259SUPPL2001-10-03
17450SUPPL2001-10-03
17449SUPPL2001-10-03