FDA.reportPublic FDA data

Application 090066

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL25MGNoYes
002DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-934Diclofenac SodiumDiclofenac SodiumBlenheim Pharmacal, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-202Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-203Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-725Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0540Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
60687-606Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
60687-606Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
61919-575DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRXANDACurrent
61919-575DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRXANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-714Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
67296-1064Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1064Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1064Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-279Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-280Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68151-0849Diclofenac SodiumDiclofenac SodiumCarilion Materials ManagementANDACurrent
68788-9175Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
80425-0102VoltarenDiclofenac Sodium 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102VoltarenDiclofenac Sodium 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0102Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent