FDA.reportPublic FDA data

Application 077214

Type
ANDA
Sponsor
ACME LABS

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
0054-0086Zolpidem Tartratezolpidem tartrateRoxane Laboratories, IncANDACurrent
0054-0087Zolpidem Tartratezolpidem tartrateRoxane Laboratories, IncANDACurrent
50436-0009ZolpidemZolpidem TartrateUnit Dose ServicesANDACurrent
63629-1170ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1170ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1171ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1171ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1171ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8998ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8998ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8999ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8999ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
68071-2642ZolpidemZolpidem TartrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2774ZolpidemZolpidem TartrateNuCare Pharmaceuticals,Inc.ANDACurrent
70934-917ZolpidemZolpidem TartrateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71205-691ZolpidemZolpidem TartrateProficient Rx LPANDACurrent
71610-670ZolpidemZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9018ORIG2007-05-01