FDA.reportPublic FDA data

Application 209946

Type
ANDA
Sponsor
ZHEJIANG JINGXIN

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
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
27808-190ColesevelamColesevelamTris Pharma IncANDACurrent
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
51407-336Colesevelam hydrochlorideColesevelam hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-336Colesevelam hydrochlorideColesevelam hydrochlorideGolden State Medical Supply, Inc.ANDACurrent