FDA.reportPublic FDA data

Application 085762

Type
ANDA
Sponsor
MYLAN

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
0378-0415Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0415Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateMylan Pharmaceuticals Inc.ANDACurrent
0615-7801Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-531Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateApotheca Inc.ANDACurrent
21695-688Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateRebel Distributors CorpANDACurrent
33261-685Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateAidarex Pharmaceuticals LLCANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0039Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
50090-0039Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
50090-0040Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
55289-102Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-102Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-102Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-254Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateProficient Rx LPANDACurrent
63187-254Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateProficient Rx LPANDACurrent
66267-082Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-082Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-780Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-780Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66336-437Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateDispensing Solutions, Inc.ANDACurrent
67296-0505Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateRedPharm Drug, Inc.ANDACurrent
67544-021Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9135Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0919Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateREMEDYREPACK INC.ANDACurrent
70518-0919Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateREMEDYREPACK INC.ANDACurrent