FDA.report

Application 090107

Type
ANDA
Sponsor
SANDOZ

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
0781-5315Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5315Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5315Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5315Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5316Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5316Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5316Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
0781-5316Zolpidem tartrateZolpidem tartrateSandoz IncANDACurrent
45865-956Zolpidem tartrateZolpidem tartratemedsource pharmaceuticalsANDACurrent
50090-2895Zolpidem tartrateZolpidem tartrateA-S Medication SolutionsANDACurrent
50436-3031Zolpidem tartrateZolpidem tartrateUnit Dose ServicesANDACurrent
55700-251Zolpidem tartrateZolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-531Zolpidem tartrateZolpidem tartrateSt. Mary's Medical Park PharmacyANDACurrent
61919-812ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent
61919-955ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent
63187-114Zolpidem tartrateZolpidem tartrateProficient Rx LPANDACurrent
63187-114Zolpidem tartrateZolpidem tartrateProficient Rx LPANDACurrent
63629-4597Zolpidem tartrateZolpidem tartrateBryant Ranch PrepackANDACurrent
63629-4597Zolpidem tartrateZolpidem tartrateBryant Ranch PrepackANDACurrent
63629-4597Zolpidem tartrateZolpidem tartrateBryant Ranch PrepackANDACurrent
63629-4708Zolpidem tartrateZolpidem tartrateBryant Ranch PrepackANDACurrent
63629-4708Zolpidem tartrateZolpidem tartrateBryant Ranch PrepackANDACurrent
63629-4708Zolpidem tartrateZolpidem tartrateBryant Ranch PrepackANDACurrent
68788-7903Zolpidem tartrateZolpidem tartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7903Zolpidem tartrateZolpidem tartratePreferred Pharmaceuticals Inc.ANDACurrent