FDA.reportPublic FDA data

Application 020404

Type
NDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003AVITATRETINOINCREAM;TOPICAL0.025%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6141AvitatretinoinMylan Pharmaceuticals Inc.NDACurrent
0378-6141AvitatretinoinMylan Pharmaceuticals Inc.NDACurrent
0472-0117TretinoinTretinoinActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0472-0117TretinoinTretinoinActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0472-0117TretinoinTretinoinActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0472-0117TretinoinTretinoinActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
50090-0651TretinoinTretinoinA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0651TretinoinTretinoinA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0651TretinoinTretinoinA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0651TretinoinTretinoinA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
53002-8100TretinoinTretinoinRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
59088-800Tretinopaktretinoin, avobenzone, octinoxate, octisalate and titanium dioxidePureTek CorporationNDA AUTHORIZED Current
59088-800Tretinopaktretinoin, avobenzone, octinoxate, octisalate and titanium dioxidePureTek CorporationNDA AUTHORIZED GENERICCurrent