FDA.reportPublic FDA data

Application 016988

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROPLEXFLUOROURACILCREAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16110-812FluoroplexfluorouracilAlmirall, LLCNDACurrent
16110-812FluoroplexfluorouracilAqua Pharmaceuticals, LLCNDACurrent
16110-812FluoroplexfluorouracilAlmirall, LLCNDACurrent
16110-812FluoroplexfluorouracilAlmirall, LLCNDACurrent
16110-812FluoroplexfluorouracilAlmirall, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70363SUPPL2022-03-02
70304SUPPL2022-03-01
10946SUPPL2016-07-27
13065SUPPL2016-07-26