FDA.reportPublic FDA data

Application 050803

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VELTINCLINDAMYCIN PHOSPHATE; TRETINOINGEL;TOPICAL1.2%;0.025%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16110-071VELTINclindamycin phosphate and tretinoinAlmirall, LLCNDACurrent
16110-071VELTINclindamycin phosphate and tretinoinAqua PharmaceuticalsNDACurrent
16110-071VELTINclindamycin phosphate and tretinoinAlmirall, LLCNDACurrent
66993-959Clindamycin Phosphate and Tretinionclindamycin phosphate and tretinoinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-959Clindamycin Phosphate and Tretinionclindamycin phosphate and tretinoinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44787ORIG2011-01-28
42747ORIG2011-01-28
39367ORIG2010-07-22
8322ORIG2010-07-20