FDA.reportPublic FDA data

Application 086727

Type
ANDA
Sponsor
ANI PHARMS INC

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
43353-594Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3452Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3452Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
53002-3400Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53002-3400Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRPK Pharmaceuticals, Inc.ANDACurrent
61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIRECT RXANDACurrent
61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect_RxANDACurrent
61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect_RxANDACurrent
62559-490Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-490Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateANI Pharmaceuticals, Inc.ANDACurrent
63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateProficient Rx LPANDACurrent
63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateProficient Rx LPANDACurrent
63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateProficient Rx LPANDACurrent
63629-1933Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-1933Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-1934Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-1934Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
67296-1572Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRedPharm Drug, Inc.ANDACurrent
68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfatePreferred Pharmaceuticals Inc.ANDACurrent
70518-3513Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.ANDACurrent
70518-3513Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.ANDACurrent
71335-0311Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
71335-0311Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent