FDA.reportPublic FDA data

Application 210316

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEFOR SUSPENSION;ORAL3.75GM/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-8860Colesevelam hydrochlorideColesevelam hydrochlorideBryant Ranch PrepackANDACurrent
63629-8860Colesevelam hydrochlorideColesevelam hydrochlorideBryant Ranch PrepackANDACurrent
63629-8860Colesevelam hydrochlorideColesevelam hydrochlorideBryant Ranch PrepackANDACurrent
63629-8860Colesevelam hydrochlorideColesevelam hydrochlorideBryant Ranch PrepackANDACurrent
67877-523Colesevelam hydrochlorideColesevelam hydrochlorideAscend Laboratories, LLCANDACurrent
67877-523Colesevelam hydrochlorideColesevelam hydrochlorideAscend Laboratories, LLCANDACurrent
67877-523Colesevelam hydrochlorideColesevelam hydrochlorideAscend Laboratories, LLCANDACurrent
67877-523Colesevelam hydrochlorideColesevelam hydrochlorideAscend Laboratories, LLCANDACurrent