FDA.reportPublic FDA data

Application 077510

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDETABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-2142COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-2142COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5211COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5211COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5211COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5211COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEImpax GenericsANDACurrent
0115-5211COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
70518-2693COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2693COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2693COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31253ORIG2006-10-26