FDA.reportPublic FDA data

Application 203828

Type
ANDA
Sponsor
INDCHEMIE HEALTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 2.5MG BASENoNo
002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5708NebivololNebivololA-S Medication SolutionsANDACurrent
50090-5752NebivololNebivololA-S Medication SolutionsANDACurrent
50090-5761NebivololNebivololA-S Medication SolutionsANDACurrent
50090-5775NebivololNebivololA-S Medication SolutionsANDACurrent
60687-641NebivololNebivololAmerican Health PackagingANDACurrent
60687-652NebivololNebivololAmerican Health PackagingANDACurrent
67877-390NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-390NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-390NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-391NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-391NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-391NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-392NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-392NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-392NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-393NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-393NebivololNebivololAscend Laboratories, LLCANDACurrent
67877-393NebivololNebivololAscend Laboratories, LLCANDACurrent
70518-3527NebivololNebivololREMEDYREPACK INC.ANDACurrent