FDA.reportPublic FDA data

Application 091600

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDETABLET;ORAL625MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEImpax GenericsANDACurrent
42291-147Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAvKARE, Inc.ANDACurrent
42291-147Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAvKARE, Inc.ANDACurrent
42291-147Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAvKAREANDACurrent
60687-385Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-385Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-385Colesevelam HydrochlorideColesevelam HydrochlorideAmerican Health PackagingANDACurrent
60687-385Colesevelam HydrochlorideColesevelam HydrochlorideAmerican Health PackagingANDACurrent
60687-385Colesevelam HydrochlorideColesevelam HydrochlorideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54441ORIG2018-06-05