FDA.reportPublic FDA data

Application 208552

Type
NDA
Sponsor
EPI HLTH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5300RHOFADEOxymetazoline HydrochlorideAllergan, Inc.NDACurrent
0023-5300RHOFADEOxymetazoline HydrochlorideAllergan, Inc.NDACurrent
0023-5300RHOFADEOxymetazoline HydrochlorideAllergan, Inc.NDACurrent
71180-003Rhofadeoxymetazoline HydrochlorideAclaris Therapeutics, Inc.NDACurrent
71180-003Rhofadeoxymetazoline HydrochlorideAclaris Therapeutics, Inc.NDACurrent
71180-003Rhofadeoxymetazoline HydrochlorideAclaris Therapeutics, Inc.NDACurrent
71403-003RhofadeOXYMETAZOLINE HYDROCHLORIDEEPI Health, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56103ORIG2018-10-26
46908ORIG2017-01-19
46916ORIG2017-01-18