FDA.reportPublic FDA data

Application 209353

Type
NDA
Sponsor
DOW PHARM

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0005AltrenotretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-0005AltrenotretinoinBausch Health US, LLCNDACurrent
0187-0005AltrenotretinoinBausch Health Americas, Inc.NDACurrent
0187-0005AltrenotretinoinBausch Health Americas, Inc.NDACurrent
0187-0005AltrenotretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-0005AltrenotretinoinBausch Health US, LLCNDACurrent
0187-0005AltrenotretinoinBausch Health Americas, Inc.NDACurrent
0187-0005AltrenotretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-0005AltrenotretinoinBausch Health Americas, Inc.NDACurrent
0187-0005AltrenotretinoinBausch Health US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57806ORIG2019-02-25
55304ORIG2018-08-24
55284ORIG2018-08-24