FDA.reportPublic FDA data

Application 201509

Type
ANDA
Sponsor
PAR FORM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;SUBLINGUAL5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;SUBLINGUAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-903Zolpidem tartrateZolpidem tartratePar Pharmaceutical, Inc.ANDACurrent
49884-903Zolpidem tartrateZolpidem tartratePar Pharmaceutical, Inc.ANDACurrent
49884-904Zolpidem tartrateZolpidem tartratePar Pharmaceutical, Inc.ANDACurrent
49884-904Zolpidem tartrateZolpidem tartratePar Pharmaceutical, Inc.ANDACurrent