FDA.reportPublic FDA data

Application 077794

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-6593OxcarbazepineOxcarbazepineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6594OxcarbazepineOxcarbazepineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6595OxcarbazepineOxcarbazepineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8153OxcarbazepineOxcarbazepineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8153OxcarbazepineOxcarbazepineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8292OxcarbazepineOxcarbazepineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8292OxcarbazepineOxcarbazepineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
33261-684OxcarbazepineOxcarbazepineAidarex Pharmaceuticals LLCANDACurrent
33261-841OxcarbazepineOxcarbazepineAidarex Pharmaceuticals LLCANDACurrent
33261-842OxcarbazepineOxcarbazepineAidarex Pharmaceuticals LLCANDACurrent
62756-183OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-183OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-183OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-184OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-184OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-184OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-185OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-185OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-185OxcarbazepineOxcarbazepineSun Pharmaceutical Industries, Inc.ANDACurrent
63629-4987OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
63629-4987OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
68788-7306OxcarbazepineOxcarbazepinePreferred Pharmaceuticals Inc.ANDACurrent
70518-1027OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1027OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1027OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1027OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1027OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1027OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1055OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1055OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1055OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1055OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1055OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1073OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1073OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1842OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1842OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1842OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1842OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1980OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1980OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
70518-1980OxcarbazepineOxcarbazepineREMEDYREPACK INC.ANDACurrent
71335-0505OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
71335-0505OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
71335-0505OxcarbazepineOxcarbazepineBryant Ranch PrepackANDACurrent
72189-339OXCARBAZEPINEOXCARBAZEPINEDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24165ORIG2007-10-23
39540ORIG2007-10-10
31290ORIG2007-10-10