FDA.reportPublic FDA data

Application 207128

Type
ANDA
Sponsor
ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDETABLET;ORAL0.025MG;2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateECI Pharmaceuticals, LLCANDACurrent
51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateECI Pharmaceuticals, LLCANDACurrent
51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateECI Pharmaceuticals, LLCANDACurrent
62135-618Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and atropine sulfateChartwell RX, LLCANDACurrent
63629-9175Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9175Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9175Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9176Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9176Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9176Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent