FDA.report

Application 204170

Type
ANDA
Sponsor
SUN PHARM

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-307Zolpidem TartrateZolpidem TartrateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-307Zolpidem TartrateZolpidem TartrateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-307Zolpidem TartrateZolpidem TartrateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-308Zolpidem TartrateZolpidem TartrateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-308Zolpidem TartrateZolpidem TartrateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-308Zolpidem TartrateZolpidem TartrateSun Pharmaceutical Industries, Inc.ANDACurrent
50090-4479Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
55700-573Zolpidem TartrateZolpidem TartrateLake Erie Medical DBA QuaANDACurrent
55700-573Zolpidem TartrateZolpidem TartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-573Zolpidem TartrateZolpidem TartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-573Zolpidem TartrateZolpidem TartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
68788-7773Zolpidem TartrateZolpidem TartratePreferred Pharmaceuticals, Inc.ANDACurrent
71335-1468Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-1468Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71610-254Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent