FDA.reportPublic FDA data

Application 076578

Type
ANDA
Sponsor
MYLAN

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
0378-5305Zolpidem Tartratezolpidem tartrateMylan Pharmaceuticals Inc.ANDACurrent
0378-5305Zolpidem Tartratezolpidem tartrateMylan Pharmaceuticals IncANDACurrent
0378-5310Zolpidem Tartratezolpidem tartrateMylan Pharmaceuticals Inc.ANDACurrent
0378-5310Zolpidem Tartratezolpidem tartrateMylan Pharmaceuticals IncANDACurrent
43353-026Zolpidem Tartratezolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-724Zolpidem Tartratezolpidem tartrateMylan Institutional Inc.ANDACurrent
51079-725Zolpidem Tartratezolpidem tartrateMylan Institutional Inc.ANDACurrent
55154-5079Zolpidem Tartratezolpidem tartrateCardinal HealthANDACurrent
55154-5079Zolpidem Tartratezolpidem tartrateCardinal HealthANDACurrent
55154-5079Zolpidem Tartratezolpidem tartrateCardinal HealthANDACurrent
55154-5080Zolpidem Tartratezolpidem tartrateCardinal HealthANDACurrent
67544-996Zolpidem Tartratezolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9278Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0161Zolpidem Tartratezolpidem tartrateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8927ORIG2007-05-01
44312ORIG2007-04-26