Application 077171

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.125MGNoNo
002CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.25MGNoNo
003CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.5MGNoNo
004CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL1MGNoYes
005CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-306ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-306ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-306ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-306ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-307ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-307ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-307ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-307ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-308ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-308ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-308ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-308ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-309ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-309ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-309ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-309ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-310ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-310ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-310ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent
49884-310ClonazepamclonazepamPar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31204SUPPL2009-12-24
31203ORIG2005-08-08