FDA.reportPublic FDA data

Application 074253

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1690Buspirone HClBuspirone hydrochlorideImpax GenericsANDACurrent
0115-1690Buspirone HClBuspirone hydrochlorideImpax GenericsANDACurrent
0115-1691Buspirone HClBuspirone hydrochlorideImpax GenericsANDACurrent
0115-1691Buspirone HClBuspirone hydrochlorideImpax GenericsANDACurrent
0115-1692Buspirone HClBuspirone hydrochlorideImpax GenericsANDACurrent
0115-1692Buspirone HClBuspirone hydrochlorideImpax GenericsANDACurrent
0591-0658Buspirone HClBuspirone hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-0718Buspirone HClBuspirone hydrochlorideActavis Pharma, Inc.ANDACurrent
10544-176Buspirone HClBuspirone hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-172Buspirone HClBuspirone hydrochlorideRebel Distributors Corp.ANDACurrent
21695-217Buspirone HClBuspirone hydrochlorideRebel Distributors Corp.ANDACurrent
21695-256Buspirone HClBuspirone hydrochlorideRebel Distributors Corp.ANDACurrent
49999-812Buspirone HydrochlorideBuspirone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1485Buspirone HClBuspirone hydrochlorideA-S Medication SolutionsANDACurrent
50090-1691Buspirone HClBuspirone hydrochlorideA-S Medication SolutionsANDACurrent
53808-0856Buspirone HClBuspirone hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0907Buspirone HClBuspirone hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55700-001Buspirone HClBuspirone hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
58517-340BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDENew Horizon Rx Group, LLCANDACurrent
63187-221Buspirone HClBuspirone hydrochlorideProficient Rx LPANDACurrent
63187-221Buspirone HClBuspirone hydrochlorideProficient Rx LPANDACurrent
63187-645Buspirone HClBuspirone hydrochlorideProficient Rx LPANDACurrent
63187-645Buspirone HClBuspirone hydrochlorideProficient Rx LPANDACurrent
63629-3047Buspirone HClBuspirone hydrochlorideBryant Ranch PrepackANDACurrent
63629-3197Buspirone HClBuspirone hydrochlorideBryant Ranch PrepackANDACurrent
63629-6366Buspirone HClBuspirone hydrochlorideBryant Ranch PrepackANDACurrent
64725-0657Buspirone HClBuspirone hydrochlorideTYA PharmaceuticalsANDACurrent
64725-0658Buspirone HClBuspirone hydrochlorideTYA PharmaceuticalsANDACurrent
66336-052Buspirone HClBuspirone hydrochlorideDispensing Solutions, Inc.ANDACurrent
67296-1081Buspirone HClBuspirone HClRedPharm Drug, Inc.ANDACurrent
67296-1081Buspirone HClBuspirone HClRedPharm Drug, Inc.ANDACurrent
68258-7087Buspirone HClBuspirone hydrochlorideDispensing Solutions, Inc.ANDACurrent
68788-0053Buspirone HClBuspirone hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30673SUPPL2003-04-09
8410SUPPL2003-04-09
30672ORIG2001-03-28