FDA.reportPublic FDA data

Application 075467

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL7.5MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-5548BusPIRone HydrochlorideBuspirone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-176Buspirone Hydrochloridebuspirone hydrochlorideAvKARE, Inc.ANDACurrent
42291-176Buspirone Hydrochloridebuspirone hydrochlorideAvKAREANDACurrent
49884-725Buspirone Hydrochloridebuspirone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-725Buspirone Hydrochloridebuspirone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-725Buspirone Hydrochloridebuspirone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-725Buspirone Hydrochloridebuspirone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
63629-6817Buspirone Hydrochloridebuspirone hydrochlorideBryant Ranch PrepackANDACurrent
63629-6817Buspirone Hydrochloridebuspirone hydrochlorideBryant Ranch PrepackANDACurrent
70518-2303Buspirone Hydrochloridebuspirone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2303Buspirone Hydrochloridebuspirone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2303Buspirone Hydrochloridebuspirone hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30896SUPPL2003-04-10
8681SUPPL2003-04-10
22474ORIG2002-07-17
30895ORIG2001-03-28