Application 077990

Type
ANDA
Sponsor
YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61442-231Zolpidem TartrateZolpidem TartrateCarlsbad Technology, Inc.ANDACurrent
61442-232Zolpidem TartrateZolpidem TartrateCarlsbad Technology, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9105ORIG2007-05-01