FDA.report

Application 076410

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0073Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0073Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0073Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0073Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0073Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0073Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0074Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0074Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0074Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0074Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0074Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0074Zolpidem TartrateZolpidem TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-8046Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8046Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8047Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8047Zolpidem TartrateZolpidem TartrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-963Zolpidem TartrateZolpidem TartrateAvKARE, Inc.ANDACurrent
42291-963Zolpidem TartrateZolpidem TartrateAvKAREANDACurrent
42291-963Zolpidem TartrateZolpidem TartrateAvKAREANDACurrent
42291-964Zolpidem TartrateZolpidem TartrateAvKARE, Inc.ANDACurrent
42291-964Zolpidem TartrateZolpidem TartrateAvKAREANDACurrent
42291-964Zolpidem TartrateZolpidem TartrateAvKAREANDACurrent
61919-803AMBIENZOLPIDEM TARTRATEDIRECT RXANDACurrent
61919-803AMBIENZOLPIDEM TARTRATEDIRECT RXANDACurrent
61919-948AMBIENZOLPIDEM TARTRATEDIRECT RXANDACurrent
61919-948AMBIENZOLPIDEM TARTRATEDIRECT RXANDACurrent
63187-682Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
63187-682Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
63187-707Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
63187-707Zolpidem TartrateZolpidem TartrateProficient Rx LPANDACurrent
67296-1591Zolpidem TartrateZolpidem TartrateRedPharm Drug, Inc.ANDACurrent
67296-1591Zolpidem TartrateZolpidem TartrateRedPharm Drug, Inc.ANDACurrent
67296-1591Zolpidem TartrateZolpidem TartrateRedPharm Drug, Inc.ANDACurrent
68071-1997Zolpidem TartrateZolpidem TartrateNuCare Pharmaceuticals, Inc.ANDACurrent
68788-8970Zolpidem TartrateZolpidem TartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-8971Zolpidem TartrateZolpidem TartratePreferred Pharmaceuticals Inc.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
70518-1663Zolpidem TartrateZolpidem TartrateREMEDYREPACK INC.ANDACurrent
71335-0283Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-0283Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-0283Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71610-272Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-273Zolpidem TartrateZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
8907ORIG2007-05-01