FDA.reportPublic FDA data

Application 085372

Type
ANDA
Sponsor
LANNETT

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
0527-1170DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELannett Company, Inc.ANDACurrent
0527-1170DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELannett Company, Inc.ANDACurrent
0527-1170DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELannett Company, Inc.ANDACurrent
60687-569Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateAmerican Health PackagingANDACurrent
60687-569Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateAmerican Health PackagingANDACurrent
67296-1675DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedPharm Drug, Inc.ANDACurrent