FDA.reportPublic FDA data

Application 213530

Type
ANDA
Sponsor
ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDECHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDECAPSULE;ORAL5MG;2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51293-696Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideECI Pharmaceuticals LLCANDACurrent
51293-696Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideECI Pharmaceuticals LLCANDACurrent
51293-696Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideECI Pharmaceuticals LLCANDACurrent
51293-696Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideECI Pharmaceuticals LLCANDACurrent
62135-696CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEChlordiazepoxide Hydrochloride and Clidinium BromideChartwell RX, LLCANDACurrent
62135-696CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEChlordiazepoxide Hydrochloride and Clidinium BromideChartwell RX, LLCANDACurrent
63629-2021Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent
63629-2021Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent
63629-2021Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent
63629-2021Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackANDACurrent