FDA.reportPublic FDA data

Application 078970

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-2354ZOLPIDEM TARTRATEZolpidem TartrateNuCare Pharmaceuticals,Inc.ANDACurrent
68180-779ZOLPIDEM TARTRATEZolpidem TartrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-779ZOLPIDEM TARTRATEZolpidem TartrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-779ZOLPIDEM TARTRATEZolpidem TartrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-780ZOLPIDEM TARTRATEZolpidem TartrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-780ZOLPIDEM TARTRATEZolpidem TartrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-780ZOLPIDEM TARTRATEZolpidem TartrateLupin Pharmaceuticals, Inc.ANDACurrent
68788-7422ZOLPIDEM TARTRATEZolpidem TartratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7422ZOLPIDEM TARTRATEZolpidem TartratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7422ZOLPIDEM TARTRATEZolpidem TartratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7422ZOLPIDEM TARTRATEZolpidem TartratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7688ZOLPIDEM TARTRATEZolpidem TartratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7688ZOLPIDEM TARTRATEZolpidem TartratePreferred Pharmaceuticals, Inc.ANDACurrent
71205-286ZOLPIDEM TARTRATEZolpidem TartrateProficient Rx LPANDACurrent
71205-286ZOLPIDEM TARTRATEZolpidem TartrateProficient Rx LPANDACurrent
71335-1180ZOLPIDEM TARTRATEZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-1180ZOLPIDEM TARTRATEZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-1180ZOLPIDEM TARTRATEZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-2085ZOLPIDEM TARTRATEZolpidem TartrateBryant Ranch PrepackANDACurrent
72189-230ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent