Application 077833

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NADOLOL AND BENDROFLUMETHIAZIDEBENDROFLUMETHIAZIDE; NADOLOLTABLET;ORAL5MG;40MGNoNo
002NADOLOL AND BENDROFLUMETHIAZIDEBENDROFLUMETHIAZIDE; NADOLOLTABLET;ORAL5MG;80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-5311Nadolol and BendroflumethiazideNADOLOL and BENDROFLUMETHIAZIDEImpax GenericsANDACurrent
0115-5322Nadolol and BendroflumethiazideNADOLOL and BENDROFLUMETHIAZIDEImpax GenericsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9087ORIG2007-04-09