FDA.reportPublic FDA data

Application 021022

Type
NDA
Sponsor
VALEANT BERMUDA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENLACCICLOPIROXSOLUTION;TOPICAL8%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5180PenlacciclopiroxBausch Health US LLCNDACurrent
0187-5180PenlacciclopiroxValeant Pharmaceuticals North America LLCNDACurrent
0187-5180PenlacciclopiroxBausch Health Americas, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
26517SUPPL2004-12-08
14192SUPPL2004-12-08
35912SUPPL2003-12-29
26516SUPPL2003-12-24
26515SUPPL2003-06-22
14191SUPPL2003-06-22
43566ORIG1999-12-17
41882ORIG1999-12-17
14190ORIG1999-12-17
4074ORIG1999-12-17