FDA.reportPublic FDA data

Application 050777

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTOPICTACROLIMUSOINTMENT;TOPICAL0.03%YesYes
002PROTOPICTACROLIMUSOINTMENT;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-5201ProtopicTacrolimusAstellas Pharma US Inc.NDACurrent
0469-5202ProtopicTacrolimusAstellas Pharma US Inc.NDACurrent
45802-390TacrolimusTacrolimusPerrigo New York IncNDACurrent
45802-390TacrolimusTacrolimusPerrigo New York IncNDACurrent
45802-700TacrolimusTacrolimusPerrigo New York IncNDACurrent
45802-700TacrolimusTacrolimusPerrigo New York IncNDACurrent
50222-203ProtopicTacrolimusLEO Pharma Inc.NDACurrent
50222-203ProtopicTacrolimusLEO Pharma Inc.NDACurrent
50222-203ProtopicTacrolimusLEO Pharma Inc.NDACurrent
50222-203ProtopicTacrolimusLEO Pharma IncNDACurrent
50222-211ProtopicTacrolimusLEO Pharma Inc.NDACurrent
50222-211ProtopicTacrolimusLEO Pharma Inc.NDACurrent
50222-211ProtopicTacrolimusLEO Pharma Inc.NDACurrent
50222-211ProtopicTacrolimusLEO Pharma IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71765SUPPL2022-08-09
71764SUPPL2022-08-09
39312SUPPL2011-11-17
30516SUPPL2011-11-08
8261SUPPL2009-01-06
30515SUPPL2006-01-30
43890SUPPL2006-01-19
39311SUPPL2006-01-19
30514SUPPL2005-07-15
23728ORIG2005-04-15
39310SUPPL2003-12-29
8260SUPPL2003-12-24
18227SUPPL2003-05-29
8259SUPPL2003-05-29
22233ORIG2003-04-22
30513ORIG2003-04-09
18226ORIG2003-04-07