FDA.reportPublic FDA data

Application 019049

Type
NDA
Sponsor
VALEANT BERMUDA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETIN-ATRETINOINCREAM;TOPICAL0.025%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5160Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5160Retin-ATretinoinBausch Health US, LLCNDACurrent
0187-5160Retin-ATretinoinBausch Health Americas Inc.NDACurrent
0187-5160Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5160Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5160Retin-ATretinoinBausch Health US, LLCNDACurrent
0187-5160Retin-ATretinoinValeant Pharmaceuticals North America LLCNDACurrent
0378-8082TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8082TretioninTretioninMylan Pharmaceuticals IncNDA AUTHORIZED Current
0378-8082TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8082TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8082TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8082TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8082TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
62032-414Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-414Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-414Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-414Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
66530-253TretinoinTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33693SUPPL2002-06-10
16182SUPPL2002-06-10
11427SUPPL2002-06-10
11426SUPPL2002-06-10
1218SUPPL2002-06-10
1217SUPPL2002-06-10