FDA.reportPublic FDA data

Application 076201

Type
ANDA
Sponsor
DEXCEL LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, EXTENDED RELEASE;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-2170Diclofenac SodiumDiclofenac SodiumLannett Company, Inc.ANDACurrent
0527-2170Diclofenac SodiumDiclofenac SodiumLannett Company, Inc.ANDACurrent
0527-2170Diclofenac SodiumDiclofenac SodiumLannett Company, Inc.ANDACurrent
0527-2170Diclofenac SodiumDiclofenac SodiumLannett Company, Inc.ANDACurrent
0527-2170Diclofenac SodiumDiclofenac SodiumLannett Company, Inc.ANDACurrent
0591-0676Diclofenac SodiumDiclofenac SodiumActavis Pharma, Inc.ANDACurrent
10544-928Diclofenac SodiumDiclofenac SodiumBlenheim Pharmacal, Inc.ANDACurrent
50090-1185Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50436-0676Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
55700-246Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-058Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
61919-468DICLOFENAC SODIUMDICLOFENAC SODIUMDirect RXANDACurrent
63187-475Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
66267-709Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
66267-709Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3325Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9523Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1903Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-1903Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-1903Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-1903Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-1903Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70934-027Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-027Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0170Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-1238Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-1238Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-1238Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-1238Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent