FDA.reportPublic FDA data

Application 019716

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPROLENEBETAMETHASONE DIPROPIONATELOTION, AUGMENTED;TOPICALEQ 0.05% BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58525SUPPL2019-05-02
58523SUPPL2019-05-02
53587SUPPL2018-04-01
53570SUPPL2018-04-01
11645SUPPL2014-08-15
19113SUPPL2014-08-14
19112SUPPL2006-09-18
11644SUPPL2006-08-28
1525SUPPL2006-04-25
33879SUPPL2005-10-14
1524SUPPL2005-10-14