FDA.reportPublic FDA data

Application 204229

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;SUBLINGUAL1.75MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;SUBLINGUAL3.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-898Zolpidem tartrate sublingualZolpidem tartrate sublingualPar Pharmaceutical, Inc.ANDACurrent
49884-898Zolpidem tartrate sublingualZolpidem tartrate sublingualPar Pharmaceutical, Inc.ANDACurrent
49884-898Zolpidem tartrate sublingualZolpidem tartrate sublingualPar Pharmaceutical, Inc.ANDACurrent
49884-899Zolpidem tartrate sublingualZolpidem tartrate sublingualPar Pharmaceutical, Inc.ANDACurrent
49884-899Zolpidem tartrate sublingualZolpidem tartrate sublingualPar Pharmaceutical, Inc.ANDACurrent
49884-899Zolpidem tartrate sublingualZolpidem tartrate sublingualPar Pharmaceutical, Inc.ANDACurrent