FDA.reportPublic FDA data

Application 075463

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTABLET;ORAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2474Diclofenac Potassiumdiclofenac potassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2474Diclofenac Potassiumdiclofenac potassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2474Diclofenac Potassiumdiclofenac potassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2474Diclofenac Potassiumdiclofenac potassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2474Diclofenac Potassiumdiclofenac potassiumMylan Pharmaceuticals Inc.ANDACurrent
50090-1535Diclofenac Potassiumdiclofenac potassiumA-S Medication SolutionsANDACurrent
50090-1535Diclofenac Potassiumdiclofenac potassiumA-S Medication SolutionsANDACurrent
63629-7969Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
63629-7969Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
67296-1746Diclofenac Potassiumdiclofenac potassiumRedPharm Drug, Inc.ANDACurrent
67296-1746Diclofenac Potassiumdiclofenac potassiumRedPharm Drug, Inc.ANDACurrent
68071-4042Diclofenac Potassiumdiclofenac potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2185Diclofenac Potassiumdiclofenac potassiumREMEDYREPACK INC.ANDACurrent
70518-2185Diclofenac Potassiumdiclofenac potassiumREMEDYREPACK INC.ANDACurrent
70518-2185Diclofenac Potassiumdiclofenac potassiumREMEDYREPACK INC.ANDACurrent
70518-2185Diclofenac Potassiumdiclofenac potassiumREMEDYREPACK INC.ANDACurrent
71335-0369Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
71335-0369Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
71335-0369Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
72789-051Diclofenac Potassiumdiclofenac potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-051Diclofenac Potassiumdiclofenac potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-051Diclofenac Potassiumdiclofenac potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-051Diclofenac Potassiumdiclofenac potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72819-151Diclofenac Potassiumdiclofenac potassiumArchis Pharma LLCANDACurrent
72819-151Diclofenac Potassiumdiclofenac potassiumArchis Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30893ORIG1999-07-26