FDA.reportPublic FDA data

Application 209696

Type
ANDA
Sponsor
INVENTIA HLTHCARE

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
005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24689-781BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-781BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-785BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-785BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-907BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-907BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-921BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-921BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-933BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
24689-933BusPIRone HydrochlorideBusPIRone HydrochlorideAPNAR PHARMA LPANDACurrent
49252-098BusPIRone HydrochlorideBusPIRone HydrochlorideInventia Healthcare Private LimitedANDACurrent
49252-099BusPIRone HydrochlorideBusPIRone HydrochlorideInventia Healthcare Private LimitedANDACurrent
49252-100BusPIRone HydrochlorideBusPIRone HydrochlorideInventia Healthcare Private LimitedANDACurrent
49252-101BusPIRone HydrochlorideBusPIRone HydrochlorideInventia Healthcare Private LimitedANDACurrent
49252-107BusPIRone HydrochlorideBusPIRone HydrochlorideInventia Healthcare Private LimitedANDACurrent
53002-5017BusPIRone HydrochlorideBusPIRone HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
71205-280BusPIRone HydrochlorideBusPIRone HydrochlorideProficient Rx LPANDACurrent
71205-280BusPIRone HydrochlorideBusPIRone HydrochlorideProficient Rx LPANDACurrent
71335-1144BusPIRone HydrochlorideBusPIRone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1144BusPIRone HydrochlorideBusPIRone HydrochlorideBryant Ranch PrepackANDACurrent
71610-281BusPIRone HydrochlorideBusPIRone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-291BusPIRone HydrochlorideBusPIRone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
75834-266Buspirone HydrochlorideBuspirone HydrochlorideNivagen Pharmaceuticals Inc.ANDACurrent
75834-267Buspirone HydrochlorideBuspirone HydrochlorideNivagen Pharmaceuticals Inc.ANDACurrent
75834-268Buspirone HydrochlorideBuspirone HydrochlorideNivagen Pharmaceuticals Inc.ANDACurrent
75834-269Buspirone HydrochlorideBuspirone HydrochlorideNivagen Pharmaceuticals Inc.ANDACurrent
75834-270Buspirone HydrochlorideBuspirone HydrochlorideNivagen Pharmaceuticals Inc.ANDACurrent