FDA.reportPublic FDA data

Application 017522

Type
NDA
Sponsor
VALEANT BERMUDA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETIN-ATRETINOINCREAM;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5162Retin-ATretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5162Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5162Retin-ATretinoinBausch Health US, LLCNDACurrent
0187-5162Retin-ATretinoinBausch Health Americas Inc.NDACurrent
0187-5162Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5162Retin-ATretinoinBausch Health US LLCNDACurrent
0187-5162Retin-ATretinoinBausch Health US, LLCNDACurrent
0378-8083TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8083TretioninTretioninMylan Pharmaceuticals IncNDA AUTHORIZED Current
0378-8083TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8083TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8083TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8083TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8083TretioninTretioninMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
42254-151TretinoinTretinoinRebel Distributors CorpANDACurrent
62032-412Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-412Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-412Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
62032-412Tretinoin CreamtretinoinObagi Cosmeceuticals LLCNDACurrent
66530-254TretinoinTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33291SUPPL2002-06-10
13167SUPPL2002-06-10
13166SUPPL2002-06-10
11009SUPPL2002-06-10
11008SUPPL2002-06-10
616SUPPL2002-06-10