FDA.reportPublic FDA data

Application 022087

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VECTICALCALCITRIOLOINTMENT;TOPICAL3MCG/GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-2012VecticalcalcitriolGalderma Laboratories, L.P.NDACurrent
0299-2012VecticalcalcitriolGalderma Laboratories, L.P.NDACurrent
0299-2012VecticalcalcitriolGalderma Laboratories, L.P.NDACurrent
0299-2012VecticalcalcitriolGalderma Laboratories, L.P.NDACurrent
45802-608calcitriolcalcitriolPerrigo New York IncNDACurrent
45802-608calcitriolcalcitriolPerrigo New York IncNDACurrent
45802-608calcitriolcalcitriolPadagis Israel Pharmaceuticals LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64052SUPPL2020-07-23
63972SUPPL2020-07-20
44676ORIG2009-08-03
21934ORIG2009-08-03
38207ORIG2009-02-04
6853ORIG2009-01-30