FDA.reportPublic FDA data

Application 077863

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL75MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-933Diclofenac SodiumDiclofenac SodiumBlenheim Pharmacal, Inc.ANDACurrent
16571-201Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-201Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
16571-201Diclofenac SodiumDiclofenac SodiumRising Pharmaceuticals, Inc.ANDACurrent
16571-201Diclofenac SodiumDiclofenac SodiumRising Pharma Holdings, Inc.ANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-714Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
42254-036Diclofenac SodiumDiclofenac SodiumRebel Distributors CorpANDACurrent
50436-2201Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
50436-6924Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
52959-423Diclofenac SodiumDiclofenac SodiumH.J. Harkins Company, Inc.ANDACurrent
60687-658Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
60760-090Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
60760-090Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
61919-060VOLTARENDICLOFENAC SODIUM D/RDirect_RxANDACurrent
61919-060VOLTARENDICLOFENAC SODIUM D/RDirect_RxANDACurrent
61919-686DICLOFENAC SODIUMDECLOFENAC SODIUMDIRECT RXANDACurrent
61919-686DICLOFENAC SODIUMDECLOFENAC SODIUMDIRECT RXANDACurrent
63187-012Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-012Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-012Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63629-6843Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-6843Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
66267-071Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
66267-071Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
66336-463Diclofenac SodiumDiclofenac SodiumDispensing Solutions, Inc.ANDACurrent
68001-281Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-281Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-281Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-281Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68001-281Diclofenac SodiumDiclofenac SodiumBluePoint LaboratoriesANDACurrent
68084-333Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
68084-333Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
68084-333Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
68084-333Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
68084-333Diclofenac SodiumDiclofenac SodiumAmerican Health PackagingANDACurrent
68387-260Diclofenac SodiumDiclofenac SodiumKeltman Pharmaceuticals Inc.ANDACurrent
68788-8193Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9231Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0037Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0914Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0914Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2715Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2715Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
71335-0456Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0456Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
75840-094PrevidolRx Analgesic PakDICLOFENAC SODIUMGenPak Solutions, LLCANDACurrent
75840-095PrevidolRx Plus Analgesic PakDICLOFENAC SODIUMGenPak Solutions, LLCANDACurrent
80425-0056VoltarenDiclofenac Sodium 75mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0056VoltarenDiclofenac Sodium 75mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0056DiclofenacDiclofenacAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0056DiclofenacDiclofenacAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0056DiclofenacDiclofenacAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent