FDA.reportPublic FDA data

Application 040728

Type
ANDA
Sponsor
ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETHANECHOL CHLORIDEBETHANECHOL CHLORIDETABLET;ORAL50MGNoNo
002BETHANECHOL CHLORIDEBETHANECHOL CHLORIDETABLET;ORAL5MGNoNo
003BETHANECHOL CHLORIDEBETHANECHOL CHLORIDETABLET;ORAL10MGNoNo
004BETHANECHOL CHLORIDEBETHANECHOL CHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51293-645Bethanechol ChlorideBethanechol ChlorideECI Pharmaceuticals LLCANDACurrent
51293-646Bethanechol ChlorideBethanechol ChlorideECI Pharmaceuticals LLCANDACurrent
51293-647Bethanechol ChlorideBethanechol ChlorideECI Pharmaceuticals LLCANDACurrent
51293-648Bethanechol ChlorideBethanechol ChlorideECI Pharmaceuticals LLCANDACurrent
63629-2022Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2022Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2023Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2023Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2024Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2024Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2025Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-2025Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent
63629-9293Bethanechol ChlorideBethanechol ChlorideBryant Ranch PrepackANDACurrent