FDA.reportPublic FDA data

Application 213413

Type
ANDA
Sponsor
LEADING PHARMA 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
50090-5589Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
50090-5592Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
53002-3401Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateRPK Pharmaceuticals, Inc.ANDACurrent
68071-2328Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8090Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePreferred Pharmaceuticals Inc.ANDACurrent
68788-8090Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePreferred Pharmaceuticals Inc.ANDACurrent
69315-910Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateLeading Pharma, LLCANDACurrent
69315-910Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateLeading Pharma, LLCANDACurrent
69315-910Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateLeading Pharma, LLCANDACurrent
71205-909Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateProficient Rx LPANDACurrent
71205-909Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateProficient Rx LPANDACurrent
71335-1693Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateBryant Ranch PrepackANDACurrent
71335-1693Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateBryant Ranch PrepackANDACurrent
72189-336DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect RxANDACurrent
72189-336DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect RxANDACurrent
72189-336DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect RxANDACurrent