FDA.reportPublic FDA data

Application 017955

Type
NDA
Sponsor
VALEANT INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETIN-ATRETINOINGEL;TOPICAL0.01%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5172Retin-ATretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5172Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5172Retin-ATretinoinBausch Health US, LLCNDACurrent
0187-5172Retin-ATretinoinBausch Health Americas Inc.NDACurrent
0187-5172Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5172Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5172Retin-ATretinoinBausch Health US, LLCNDACurrent
0378-8085TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8085TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8085TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8085TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8085TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8085TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8085TretioninTretioninMylan Pharmaceuticals IncNDA AUTHORIZED Current
66530-256TretinoinTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent
66530-256TretinoinTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33374SUPPL2002-06-10
13960SUPPL2002-06-10
13959SUPPL2002-06-10
11096SUPPL2002-06-10
11095SUPPL2002-06-10
755SUPPL2002-06-10