FDA.reportPublic FDA data

Application 017340

Type
NDA
Sponsor
VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETIN-ATRETINOINCREAM;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5164Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5164Retin-ATretinoinBausch Health US, LLCNDACurrent
0187-5164Retin-ATretinoinBausch Health Americas Inc.NDACurrent
0187-5164Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5164Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5164Retin-ATretinoinBausch Health US, LLCNDACurrent
0187-5164Retin-ATretinoinValeant Pharmaceuticals North America LLCNDACurrent
0378-8084TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8084TretioninTretioninMylan Pharmaceuticals IncNDA AUTHORIZED Current
0378-8084TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8084TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8084TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8084TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8084TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62032-417Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-417Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-417Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-417Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
66530-255TretinoinTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33241SUPPL2002-06-10
33240SUPPL2002-06-10
13107SUPPL2002-06-10
10975SUPPL2002-06-10
562SUPPL2002-06-10
561SUPPL2002-06-10