FDA.reportPublic FDA data

Application 077277

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEGRANULE;ORAL5GM/SCOOPFULNoNo
002COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEGRANULE;ORAL5GM/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-5212COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEImpax GenericsANDACurrent
0115-5212COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5212COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5212COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5213COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEImpax GenericsANDACurrent
0115-5213COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5213COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5213COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9030ORIG2006-05-03