FDA.reportPublic FDA data

Application 201615

Type
ANDA
Sponsor
TOLMAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CALCIPOTRIENEOINTMENT;TOPICAL0.064%;0.005%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-7165CALCIPOTRIENE 0.005% AND BETAMETHASONE DIPROPIONATE 0.064%calcipotriene 0.005% and betamethasone dipropionate 0.064%Sandoz Inc.ANDACurrent
0781-7165CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEcalcipotriene and betamethasone dipropionateSandoz Inc.ANDACurrent
0781-7165CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEcalcipotriene and betamethasone dipropionateSandoz Inc.ANDACurrent
0781-7165CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEcalcipotriene and betamethasone dipropionateSandoz Inc.ANDACurrent
0781-7165CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEcalcipotriene and betamethasone dipropionateSandoz Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32122ORIG2013-01-17