FDA.reportPublic FDA data

Application 210571

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0832-0590Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfateUpsher-Smith Laboratories, LLCANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, InANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
71610-566Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent