FDA.reportPublic FDA data

Application 078088

Type
ANDA
Sponsor
PAR PHARM

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-110AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-110AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-110AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-110AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-111AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-111AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-111AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-111AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-213AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-213AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-213AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-213AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-214AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-214AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-214AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent
49884-214AlprazolamalprazolamPar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9115ORIG2009-01-12
31328ORIG2007-09-25