FDA.report

Application 075022

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoYes
004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL30MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0053Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0053Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0053Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0053Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0053Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0054Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0054Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0054Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0054Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0054Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1003Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1003Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1003Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1003Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1003Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5200Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5200Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5200Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5200Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5200Buspirone HydrochlorideBuspirone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7633Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7634Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7635Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7689Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7689Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7689Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7714Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7714Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7714Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7718Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7718Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7718Buspirone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
33261-014Buspirone HydrochlorideBuspirone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-015Buspirone HydrochlorideBuspirone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42254-126Buspirone HydrochlorideBuspirone HydrochlorideRebel Distributors CorpANDACurrent
42291-177Buspirone HydrochlorideBuspirone HydrochlorideAvKARE, Inc.ANDACurrent
42291-177Buspirone HydrochlorideBuspirone HydrochlorideAvKAREANDACurrent
45865-887Buspirone HydrochlorideBuspirone Hydrochloridemedsource pharmaceuticalsANDACurrent
50090-4182Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-4182Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-4182Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-4862Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-4862Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-4862Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-5886Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
51655-015BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
52959-676Buspirone HydrochlorideBuspirone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53002-1017Buspirone HydrochlorideBuspirone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1017Buspirone HydrochlorideBuspirone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1424Buspirone HydrochlorideBuspirone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
61919-579BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDirect RxANDACurrent
61919-579BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDirect RxANDACurrent
61919-579BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDirect RxANDACurrent
61919-579BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDirect RxANDACurrent
63187-402Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63187-402Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63187-402Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63187-904Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63187-904Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63187-904Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63187-904Buspirone HydrochlorideBuspirone HydrochlorideProficient Rx LPANDACurrent
63629-1747Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
63629-3333Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
63629-3333Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
67296-0925Buspirone HydrochlorideBuspirone HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0925Buspirone HydrochlorideBuspirone HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0925Buspirone HydrochlorideBuspirone HydrochlorideRedPharm Drug, Inc.ANDACurrent
68151-1437Buspirone HydrochlorideBuspirone HydrochlorideCarilion Materials ManagementANDACurrent
68151-1438Buspirone HydrochlorideBuspirone HydrochlorideCarilion Materials ManagementANDACurrent
68788-5665Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9844Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9845Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1687Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1687Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1747Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1747Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1747Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1747Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1924Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1924Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent