FDA.reportPublic FDA data

Application 075219

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0948Diclofenac PotassiumDiclofenac PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-838Diclofenac PotassiumDiclofenac PotassiumRebel Distributors CorpANDACurrent
33261-038Diclofenac PotassiumDiclofenac PotassiumAidarex Pharmaceuticals LLCANDACurrent
35356-713Diclofenac PotassiumDiclofenac PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-713Diclofenac PotassiumDiclofenac PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-713Diclofenac PotassiumDiclofenac PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-713Diclofenac PotassiumDiclofenac PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-848Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-848Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-848Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-848Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-848Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0646Diclofenac PotassiumDiclofenac PotassiumA-S Medication SolutionsANDACurrent
50090-0646Diclofenac PotassiumDiclofenac PotassiumA-S Medication SolutionsANDACurrent
50090-0646Diclofenac PotassiumDiclofenac PotassiumA-S Medication SolutionsANDACurrent
50090-0646Diclofenac PotassiumDiclofenac PotassiumA-S Medication SolutionsANDACurrent
52959-659Diclofenac PotassiumDiclofenac PotassiumH.J. Harkins Company, Inc.ANDACurrent
53002-1176Diclofenac PotassiumDiclofenac PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1176Diclofenac PotassiumDiclofenac PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
61919-072DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMDIRECT RXANDACurrent
61919-072DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMDIRECT RXANDACurrent
63629-4108Diclofenac PotassiumDiclofenac PotassiumBryant Ranch PrepackANDACurrent
63629-4108Diclofenac PotassiumDiclofenac PotassiumBryant Ranch PrepackANDACurrent
63629-4108Diclofenac PotassiumDiclofenac PotassiumBryant Ranch PrepackANDACurrent
66267-070Diclofenac PotassiumDiclofenac PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
66267-070Diclofenac PotassiumDiclofenac PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
66267-070Diclofenac PotassiumDiclofenac PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1316Diclofenac PotassiumDiclofenac PotassiumRedPharm Drug, Inc.ANDACurrent
67296-1316Diclofenac PotassiumDiclofenac PotassiumRedPharm Drug, Inc.ANDACurrent
67296-1316Diclofenac PotassiumDiclofenac PotassiumRedPharm Drug, Inc.ANDACurrent
68151-0561Diclofenac PotassiumDiclofenac PotassiumCarilion Materials ManagementANDACurrent
70518-3072Diclofenac PotassiumDiclofenac PotassiumREMEDYREPACK INC.ANDACurrent
70518-3072Diclofenac PotassiumDiclofenac PotassiumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30799ORIG1998-08-06