FDA.reportPublic FDA data

Application 021159

Type
NDA
Sponsor
BAUSCH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0522CiclopiroxciclopiroxE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
99207-010LoproxciclopiroxBausch Health US, LLCNDACurrent
99207-010LoproxciclopiroxValeant Pharmaceuticals North America LLCNDACurrent
99207-010LoproxciclopiroxBausch Health US, LLCNDACurrent
99207-010LoproxciclopiroxBausch Health US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
36243SUPPL2013-05-14
4504SUPPL2013-05-10
4503SUPPL2012-12-11
36242SUPPL2012-12-07
36241SUPPL2006-06-14
26938SUPPL2006-06-14
4502SUPPL2004-02-27
41994ORIG2003-07-08
26937ORIG2003-03-10
36240ORIG2003-02-28