Application 078413

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL10MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8225Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8225Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8226Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8226Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
16714-621Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-621Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-621Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-621Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-622Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-622Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-622Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
16714-622Zolpidem TartrateZolpidem TartrateNorthStar Rx LLCANDACurrent
50090-2649Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3878Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3878Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3878Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3878Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3878Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3879Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3879Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3879Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3879Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-3879Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-5095Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-5096Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
50090-6070Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
63739-526Zolpidem TartrateZolpidem TartrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-526Zolpidem TartrateZolpidem TartrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-526Zolpidem TartrateZolpidem TartrateMcKesson Corporation dba SKY PackagingANDACurrent
65862-159Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-159Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-159Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-159Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-160Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-160Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-160Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
65862-160Zolpidem TartrateZolpidem TartrateAurobindo Pharma LimitedANDACurrent
67296-0537Zolpidem TartrateZolpidem TartrateRedPharm Drug, Inc.ANDACurrent
68788-9282Zolpidem TartrateZolpidem TartratePreferred Pharmaceuticals, Inc.ANDACurrent
71610-151Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-152Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-156Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-192Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0061AmbienZolpidem Tartrate 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0061AmbienZolpidem Tartrate 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0061Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0061Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0087AmbienZolpidem Tartrate 5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0087Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0087Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0153AmbienZolpidem Tartrate 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0153Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0153Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0153Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
44381ORIG2007-05-15