FDA.reportPublic FDA data

Application 078148

Type
ANDA
Sponsor
ANCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL12.5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL6.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10370-116Zolpidem TartrateZolpidem TartratePar Pharmaceutical, Inc.ANDACurrent
10370-116Zolpidem TartrateZolpidem TartratePar Pharmaceutical, Inc.ANDACurrent
10370-116Zolpidem TartrateZolpidem TartratePar Pharmaceutical, Inc.ANDACurrent
10370-117Zolpidem TartrateZolpidem TartratePar Pharmaceutical, Inc.ANDACurrent
10370-117Zolpidem TartrateZolpidem TartratePar Pharmaceutical, Inc.ANDACurrent
10370-117Zolpidem TartrateZolpidem TartratePar Pharmaceutical, Inc.ANDACurrent
50090-3994Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50436-0116Zolpidem TartrateZolpidem TartrateUnit Dose ServicesANDACurrent
51407-554Zolpidem TartrateZolpidem TartrateGolden State Medical SupplyANDACurrent
51407-555Zolpidem TartrateZolpidem TartrateGolden State Medical SupplyANDACurrent
55700-777Zolpidem TartrateZolpidem TartrateQuality Care Products, LLCANDACurrent
55700-777Zolpidem TartrateZolpidem TartrateQuality Care Products, LLCANDACurrent
60760-116Zolpidem Tartrate Extended ReleaseZOLPIDEM TARTRATESt Marys Medical Park PharmacyANDACurrent
71335-1801Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-1801Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71610-564Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31338ORIG2010-12-07