FDA.reportPublic FDA data

Application 077449

Type
ANDA
Sponsor
AVEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTANYL-25FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL25MCG/HRNoNo
002FENTANYL-50FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL50MCG/HRNoNo
003FENTANYL-75FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL75MCG/HRNoNo
004FENTANYL-100FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL100MCG/HRNoNo
005FENTANYL-12FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL12.5MCG/HRNoNo
006FENTANYL-37FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL37.5MCG/HRNoNo
007FENTANYL-62FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL62.5MCG/HRNoNo
008FENTANYL-87FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL87.5MCG/HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-402FENTANYLFENTANYLLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-748FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-748FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-748FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-748FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-749FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-749FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-749FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-749FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-753FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-753FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-753FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-772FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-772FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
55700-811FENTANYLFENTANYLQuality Care Products, LLCANDACurrent
60505-7006FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7006FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7006FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7006FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7006FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7007FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7007FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7007FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7007FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7007FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7008FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7008FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7008FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7008FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7008FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7009FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7009FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7009FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7009FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7009FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7010FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7010FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7010FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7010FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7010FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7011FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7011FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7011FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7011FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7011FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7012FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7012FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7012FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7012FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7012FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7013FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7013FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7013FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7013FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7013FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7014FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7014FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7014FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7014FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7014FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7015FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7015FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7015FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7016FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7016FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7016FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7017FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7017FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7017FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7080FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7080FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7080FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7080FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7080FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7081FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7081FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7081FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7081FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7081FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7082FENTANYLFENTANYLApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24062ORIG2015-06-30
22605ORIG2014-01-17