FDA.reportPublic FDA data

Application 204582

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoNo
004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7121Buspirone HydrochlorideBuspirone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7122Buspirone HydrochlorideBuspirone HydrochlorideMajor PharmaceuticalsANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
55700-861Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
67046-558Buspirone HydrochlorideBuspirone HydrochlorideContract Pharmacy Services-PAANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2300Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2300Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2300Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1605Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1605Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1605Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1608Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1608Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71610-267Buspirone HydrochlorideBuspirone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32569ORIG2015-09-24