FDA.reportPublic FDA data

Application 077322

Type
ANDA
Sponsor
SANDOZ INC

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
0781-5317Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5317Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5317Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5317Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5318Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5318Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5318Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
0781-5318Zolpidem TartrateZolpidem TartrateSandoz IncANDACurrent
50090-2630Zolpidem TartrateZolpidem TartrateA-S Medication SolutionsANDACurrent
63187-690Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
63187-690Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
63187-691Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
63187-691Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
68084-189Zolpidem TartrateZolpidem TartrateAmerican Health PackagingANDACurrent
68084-189Zolpidem TartrateZolpidem TartrateAmerican Health PackagingANDACurrent
68084-189Zolpidem TartrateZolpidem TartrateAmerican Health PackagingANDACurrent
80425-0060AmbienZolpidem Tartrate 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0060Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0060Zolpidem TartrateZolpidem TartrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39526ORIG2007-05-01
31223ORIG2007-05-01