FDA.reportPublic FDA data

Application 018741

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPROLENEBETAMETHASONE DIPROPIONATEOINTMENT, AUGMENTED;TOPICALEQ 0.05% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-0575DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0575DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0575DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0575DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0575DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
66993-897Betamethasone Dipropionatebetamethasone dipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-897Betamethasone Dipropionatebetamethasone dipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-897Betamethasone Dipropionatebetamethasone dipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-897Betamethasone Dipropionatebetamethasone dipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-897Betamethasone Dipropionatebetamethasone dipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-897Betamethasone Dipropionatebetamethasone dipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
78206-124DIPROLENEbetamethasone dipropionateOrganon LLCNDACurrent
78206-124DIPROLENEbetamethasone dipropionateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58527SUPPL2019-05-02
58521SUPPL2019-05-02
53585SUPPL2018-04-01
53568SUPPL2018-04-01
33589SUPPL2014-08-15
16024SUPPL2014-08-14
1060SUPPL2006-09-18
33588SUPPL2006-08-29
16023SUPPL2006-02-22
11314SUPPL2006-02-22
33587SUPPL2005-10-14
16022SUPPL2005-10-14