FDA.reportPublic FDA data

Application 022070

Type
NDA
Sponsor
DOW PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATRALINTRETINOINGEL;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13548-070AtralinTretinoinCoria LaboratoriesNDACurrent
13548-070AtralinTretinoinBausch Health US, LLCNDACurrent
62032-413TretinoinTretinoinObagi Cosmeceuticals LLCNDA AUTHORIZED GENERICCurrent
62032-413TretinoinTretinoinObagi Cosmeceuticals LLCNDA AUTHORIZED GENERICCurrent
62032-413TretinoinTretinoinObagi Cosmeceuticals LLCNDA AUTHORIZED GENERICCurrent
62032-413TretinoinTretinoinObagi Cosmeceuticals LLCNDA AUTHORIZED GENERICCurrent
68682-800TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-800TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29201SUPPL2014-09-03
16892SUPPL2014-09-03
21925ORIG2009-03-05
38188ORIG2007-07-30
6821ORIG2007-07-30