FDA.reportPublic FDA data

Application 078616

Type
ANDA
Sponsor
VINTAGE

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
10544-539Zolpidem Tartratezolpidem tartrateBlenheim Pharmacal, Inc.ANDACurrent
10544-540Zolpidem Tartratezolpidem tartrateBlenheim Pharmacal, Inc.ANDACurrent
10544-548Zolpidem Tartratezolpidem tartrateBlenheim Pharmacal, Inc.ANDACurrent
43353-617Zolpidem Tartratezolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-620Zolpidem Tartratezolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50436-3026Zolpidem Tartratezolpidem tartrateUnit Dose ServicesANDACurrent
50436-3030Zolpidem Tartratezolpidem tartrateUnit Dose ServicesANDACurrent
61919-527ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent
61919-528ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent
63187-115Zolpidem Tartratezolpidem tartrateProficient Rx LPANDACurrent
63187-116Zolpidem Tartratezolpidem tartrateProficient Rx LPANDACurrent
63629-3548Zolpidem Tartratezolpidem tartrateBryant Ranch PrepackANDACurrent
66336-460Zolpidem Tartratezolpidem tartrateDispensing Solutions, Inc.ANDACurrent
66336-718Zolpidem Tartratezolpidem tartrateDispensing Solutions, Inc.ANDACurrent
66336-718Zolpidem Tartratezolpidem tartrateDispensing Solutions, Inc.ANDACurrent
67296-0759Zolpidem TartrateZolpidem TartrateRedPharm Drug Inc.ANDACurrent
67296-0803Zolpidem Tartratezolpidem tartrateRedPharm Drug Inc.ANDACurrent
75921-469Zolpidem Tartratezolpidem tartrateLife Line Home Care Services, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44389ORIG2009-01-06